DOCSLIB.ORG

Benlysta, INN- Belimumab

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Benlysta, INN- Belimumab Assessment report Benlysta International Non proprietary Name: belimumab Procedure No. EMEA/H/C/002015 Assessment Report as adopted by the CHMP with all information of a commercially confidential nature deleted 7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7523 7455 E-mail [email protected] Website www.ema.europa.eu An agency of the European Union Product information Name of the medicinal product: Benlysta Marketing Authorisation Holder: Glaxo Group Limited Glaxo Wellcome House Berkeley Avenue Greenford, Middlesex UB6 0NN United Kingdom Active substance: belimumab International Non-proprietary Name: belimumab Pharmaco-therapeutic group Selective immunosuppressants (ATC Code): (L04AA26) Add-on therapy in adult patients with active Therapeutic indication: autoantibody-positive systemic lupus erythematosus (SLE) with a high degree of disease activity (e.g. positive anti-dsDNA and low complement) despite standard therapy. Pharmaceutical form: Powder for concentrate for solution for infusion Strengths: 120 mg and 400 mg Route of administration: Intravenous use Packaging: vial (glass) Package size: 1 vial Assessment report Benlysta Page 2/94 Table of contents 1. Background information on the procedure .............................................. 6 1.1. Submission of the dossier.................................................................................... 6 1.2. Steps taken for the assessment of the product ....................................................... 6 2. Scientific discussion ................................................................................ 7 2.1. Introduction ...................................................................................................... 7 2.2. Quality aspects .................................................................................................. 9 2.2.1. Introduction ................................................................................................... 9 2.2.2. Active substance ............................................................................................. 9 2.2.3. Finished Medicinal Product .............................................................................. 11 2.2.4. Discussion on chemical, pharmaceutical and biological aspects............................. 12 2.2.5. Conclusions on the chemical, pharmaceutical and biological aspects ..................... 13 2.3. Non-clinical aspects .......................................................................................... 14 2.3.1. Introduction ................................................................................................. 14 2.3.2. Pharmacology ............................................................................................... 14 2.3.3. Pharmacokinetics .......................................................................................... 16 2.3.4. Toxicology.................................................................................................... 17 2.3.5. Ecotoxicity/environmental risk assessment........................................................ 23 2.3.6. Discussion on non-clinical aspects.................................................................... 23 2.3.7. Conclusion on the non-clinical aspects .............................................................. 24 2.4. Clinical aspects ................................................................................................ 24 2.4.1. Introduction ................................................................................................. 24 2.4.2. Pharmacokinetics .......................................................................................... 26 2.4.3. Pharmacodynamics........................................................................................ 31 2.4.4. Discussion and conslusion clinical pharmacology ................................................ 32 2.5. Clinical efficacy ................................................................................................ 33 2.5.1. Dose response studies.................................................................................... 33 2.5.2. Main studies ................................................................................................. 34 2.5.3. Discussion on clinical efficacy .......................................................................... 59 2.5.4. Conclusions on the clinical efficacy ................................................................... 64 2.6. Clinical safety .................................................................................................. 65 2.6.1. Discussion on clinical safety ............................................................................ 81 2.6.2. Conclusions on the clinical safety ..................................................................... 81 2.7. Pharmacovigilance............................................................................................ 82 2.8. Benefit-risk balance.......................................................................................... 88 2.8.1. Discussion on the benefit-risk balance .............................................................. 93 2.8.2. Risk management plan................................................................................... 94 2.8.3. Similarity with authorised orphan medicinal products.......................................... 94 2.8.4. Market exclusivity.......................................................................................... 94 2.8.5. Significance of paediatric studies ..................................................................... 94 2.8.6. Conformity with agreed Paediatric Investigation Plan .......................................... 94 2.9. Recommendation ............................................................................................. 94 Assessment report Benlysta Page 3/94 List of abbreviations aCl anticardiolipin (antibody) ACR American College of Rheumatology ADA anti-drug antibodies ADME absorption, distribution, metabolism, excretion AE adverse event ALT alanine transaminase ANA antinuclear antibody ANC absolute neutrophil count ANOVA analysis of variance APTT activated partial thromboplastin time ARISg Adverse Reaction Information System – Global (HGS safety database) AST aspartate transaminase ATC Anatomical Therapeutic Chemical classification system BILAG British Isles Lupus Assessment Group BLyS B lymphocyte stimulator protein BLA Biologics Licensing Application BMI body mass index Bpm beats per minute BUN blood urea nitrogen CBER Center for Biologics Evaluation and Research CCP cyclic citrullinated peptide CDIR cytokine-dependent infusion reaction CI confidence interval CL total body clearance of drug CMV Cytomegalovirus CNS central nervous system COPD chronic obstructive pulmonary disease CRD controlled repeat dose CRP C-reactive protein CSR clinical study report CT computed tomography dL Deciliter DMARD disease-modifying anti-rheumatic drug DMC data monitoring committee DMID Division of Microbiology and Infectious Disease dsDNA double-stranded deoxyribonucleic acid ECG Electrocardiogram ECL Electrochemiluminescence ELISA enzyme-linked immunosorbent assay EMA European Medicines Agency EOP2 End of Phase 2 ER emergency room FDA Food and Drug Administration G Gram GGT gamma-glutamyl transferase GLP Good Laboratory Practice hERG human ether-a-go-go related-gene HGS Human Genome Sciences HLGT high level group term HLT high level term HMG-CoA 3-hydroxy-3-methylglutaryl coenzyme A HSR hypersensitivity reaction ICH International Conference on Harmonization Assessment report Benlysta Page 4/94 Ig Immunoglobulin INN International Nonproprietary Name IS Immunosuppressant ITT intention-to-treat IU international units IV Intravenous Kg Kilogram LDH lactic dehydrogenase LLN lower limit of normal LLOQ lower limit of quantification LOD limit of detection LRTI lower respiratory tract infection Mcg Microgram MedDRA Medical Dictionary for Regulatory Activities Mg Milligram MITT modified intent-to treat mL Milliliter MMF mycophenolate mofetil mmHg millimeters of mercury MRT mean residence time following intravenous dosing MTX Methotrexate NMSC non-melanoma skin cancer NSAID non-steroidal anti-inflammatory drug NSCLC non-small cell lung cancer PGA Physician Global Assessment PK Pharmacokinetics PT prothrombin time PTT partial thromboplastin time RA rheumatoid arthritis RBC red blood cell (count) RF rheumatoid factor RR relative risk SAE serious adverse event SC Subcutaneous SELENA Safety of Estrogen in Lupus National Assessment SLE systemic lupus erythematosus SLEDAI Systemic Lupus Erythematosus Disease Activity Index SLICC Systemic Lupus International Collaborating Clinics SMQ Standardised MedDRA Query SNF skilled nursing facility SOC system organ class SS Sjögren’s syndrome TNF tumor necrosis factor TQT thorough QT ULN upper limit of normal URTI upper respiratory tract infection US United States USAN United States Adopted Name UTI urinary tract infection TK Toxicokinetic V2 volume of distribution for the peripheral compartment Vss volume of distribution at steady-state WBC white blood cell (count) WHO World Health Organization WM Waldenström’s macroglobulinemia Assessment report Benlysta Page 5/94 1. Background information on the procedure 1.1. Submission of the dossier The applicant Glaxo Group Limited submitted on 4 June 2010 an application for Marketing Authorisation to the European Medicines Agency (EMA) for Benlysta,
Load more

Recommended publications
  • BAFF-Neutralizing Interaction of Belimumab Related to Its Therapeutic Efficacy for Treating Systemic Lupus Erythematosus
    ARTICLE DOI: 10.1038/s41467-018-03620-2 OPEN BAFF-neutralizing interaction of belimumab related to its therapeutic efficacy for treating systemic lupus erythematosus Woori Shin1, Hyun Tae Lee1, Heejin Lim1, Sang Hyung Lee1, Ji Young Son1, Jee Un Lee1, Ki-Young Yoo1, Seong Eon Ryu2, Jaejun Rhie1, Ju Yeon Lee1 & Yong-Seok Heo1 1234567890():,; BAFF, a member of the TNF superfamily, has been recognized as a good target for auto- immune diseases. Belimumab, an anti-BAFF monoclonal antibody, was approved by the FDA for use in treating systemic lupus erythematosus. However, the molecular basis of BAFF neutralization by belimumab remains unclear. Here our crystal structure of the BAFF–belimumab Fab complex shows the precise epitope and the BAFF-neutralizing mechanism of belimumab, and demonstrates that the therapeutic activity of belimumab involves not only antagonizing the BAFF–receptor interaction, but also disrupting the for- mation of the more active BAFF 60-mer to favor the induction of the less active BAFF trimer through interaction with the flap region of BAFF. In addition, the belimumab HCDR3 loop mimics the DxL(V/L) motif of BAFF receptors, thereby binding to BAFF in a similar manner as endogenous BAFF receptors. Our data thus provides insights for the design of new drugs targeting BAFF for the treatment of autoimmune diseases. 1 Department of Chemistry, Konkuk University, 120 Neungdong-ro, Gwangjin-gu, Seoul 05029, Republic of Korea. 2 Department of Bio Engineering, Hanyang University, 222 Wangsimni-ro, Seongdong-gu, Seoul 04763, Republic of Korea. These authors contributed equally: Woori Shin, Hyun Tae Lee, Heejin Lim, Sang Hyung Lee.
    [Show full text]
  • Old and New Challenges in Uveitis Associated with Behçet's Disease
    Journal of Clinical Medicine Review Old and New Challenges in Uveitis Associated with Behçet’s Disease Julie Gueudry 1,* , Mathilde Leclercq 2, David Saadoun 3,4,5 and Bahram Bodaghi 6 1 Department of Ophthalmology, Hôpital Charles Nicolle, F-76000 Rouen, France 2 Department of Internal Medicine, Hôpital Charles Nicolle, F-76000 Rouen, France; [email protected] 3 Department of Internal Medicine and Clinical Immunology, AP-HP, Centre National de Références Maladies Autoimmunes et Systémiques Rares et Maladies Autoinflammatoires Rares, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] 4 Sorbonne Universités, UPMC Univ Paris 06, INSERM, UMR S 959, Immunology-Immunopathology-Immunotherapy (I3), F-75005 Paris, France 5 Biotherapy (CIC-BTi), Hôpital Pitié-Salpêtrière, AP-HP, F-75651 Paris, France 6 Department of Ophthalmology, IHU FOReSIGHT, Sorbonne-AP-HP, Groupe Hospitalier Pitié-Salpêtrière, F-75013 Paris, France; [email protected] * Correspondence: [email protected]; Tel.: +33-2-32-88-80-57 Abstract: Behçet’s disease (BD) is a systemic vasculitis disease of unknown origin occurring in young people, which can be venous, arterial or both, classically occlusive. Ocular involvement is particularly frequent and severe; vascular occlusion secondary to retinal vasculitis may lead to rapid and severe loss of vision. Biologics have transformed the management of intraocular inflammation. However, the diagnosis of BD is still a major challenge. In the absence of a reliable biological marker, diagnosis is based on clinical diagnostic criteria and may be delayed after the appearance of the onset sign. However, therapeutic management of BD needs to be introduced early in order to control inflammation, to preserve visual function and to limit irreversible structural damage.
    [Show full text]
  • Ocrevus (Ocrelizumab) Policy Number: C11250-A
    Prior Authorization Criteria Ocrevus (ocrelizumab) Policy Number: C11250-A CRITERIA EFFECTIVE DATES: ORIGINAL EFFECTIVE DATE LAST REVIEWED DATE NEXT REVIEW DUE BY OR BEFORE 8/1/2017 2/17/2021 4/26/2022 LAST P&T J CODE TYPE OF CRITERIA APPROVAL/VERSION J2350-injection,ocrelizumab, Q2 2021 RxPA 1mg 20200428C11250-A PRODUCTS AFFECTED: Ocrevus (ocrelizumab) DRUG CLASS: Multiple Sclerosis Agents - Monoclonal Antibodies ROUTE OF ADMINISTRATION: Intravenous PLACE OF SERVICE: Specialty Pharmacy or Buy and Bill The recommendation is that medications in this policy will be for pharmacy benefit coverage and the IV infusion products administered in a place of service that is a non-hospital facility-based location (i.e., home infusion provider, provider’s office, free-standing ambulatory infusion center) AVAILABLE DOSAGE FORMS: Ocrevus SOLN 300MG/10ML FDA-APPROVED USES: Indicated for the treatment of: • Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing- remitting disease, and active secondary progressive disease, in adults • Primary progressive MS, in adults COMPENDIAL APPROVED OFF-LABELED USES: None COVERAGE CRITERIA: INITIAL AUTHORIZATION DIAGNOSIS: Multiple Sclerosis REQUIRED MEDICAL INFORMATION: A. RELAPSING FORMS OF MULTIPLE SCLEROSIS: 1. Documentation of a definitive diagnosis of a relapsing form of multiple sclerosis as defined by the McDonald criteria (see Appendix), including: Relapsing- remitting multiple sclerosis [RRMS], secondary-progressive multiple sclerosis [SPMS] with relapses, and progressive- relapsing multiple sclerosis [PRMS] or First clinical episode with MRI features consistent with multiple sclerosis Molina Healthcare, Inc. confidential and proprietary © 2021 This document contains confidential and proprietary information of Molina Healthcare and cannot be reproduced, distributed, or printed without written permission from Molina Healthcare.
    [Show full text]
  • Clinical Policy: Baricitinib (Olumiant) Reference Number: ERX.SPA.291 Effective Date: 07.24.18 Last Review Date: 11.18 Revision Log
    Clinical Policy: Baricitinib (Olumiant) Reference Number: ERX.SPA.291 Effective Date: 07.24.18 Last Review Date: 11.18 Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description Baricitinib (Olumiant®) is Janus kinase (JAK) inhibitor. FDA Approved Indication(s) Olumiant is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies. Limitation(s) of use: Use of Olumiant in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Envolve Pharmacy Solutions™ that Olumiant is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Rheumatoid Arthritis (must meet all): 1. Diagnosis of RA; 2. Prescribed by or in consultation with a rheumatologist; 3. Age ≥ 18 years; 4. Member meets one of the following (a or b): a. Failure of a ≥ 3 consecutive month trial of methotrexate (MTX) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; b. If intolerance or contraindication to MTX (see Appendix D), failure of a ≥ 3 consecutive month trial of at least ONE conventional DMARD (e.g., sulfasalazine, leflunomide, hydroxychloroquine) at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 5.
    [Show full text]
  • Immunosuppressant Drugs Therapy with COVID-19
    Immunosuppressant Drugs Therapy with COVID-19: Associated Risks, Drug-Drug Interactions & Contraindications Debjyoti Talukdar1, Diane Ignacio2, and Madan Mohan Gupta2 1Teerthanker Mahaveer University 2The University of the West Indies at St Augustine September 24, 2020 Abstract Immunosuppressant drugs like Etanercept, Mycophenolate mofetil, Sirolimus, Cyclosporine and Rituximab can weaken the immune system and make patients susceptible to SARS nCoV-2 virus. These drugs make immunocompromised persons more vulnerable to complications associated with COVID-19. Moreover, it can also increase the mortality and morbidity, as a weakened immune system can lead to longer duration of infection. This study discusses the guidelines on immunosuppressant drugs and its associated risk factors with COVID-19, issued by the U.S CDC (Centers for Disease Control and Prevention), WHO (World Health Organisation), U.S FDA (Food and Drug Administration) and other accredited global health organisa- tions. Moreover, it also includes information about pharmaceutical properties, mechanism of action, COVID-19 associated risk factors, adverse drug reactions, contraindications and drug-drug interactions. Our study will help government partners and international health organisations to better understand COVID-19 health risks associated with immunosuppressants. Increased public awareness about effective drug therapy for autoimmune diseases, cancer treatment, immunocompromised and organ transplant patients will help lower the mortality and morbidity associated with the disease amid COVID-19 pandemic. 1. INTRODUCTION As per the U.S Department of Health and Human Services and U.S FDA, immunosuppressant drugs can cause susceptibility to viruses leading to infection with increase in morbidity of the disease. It can cause severe risk of illness from COVID-19 due to a weakened immune system.
    [Show full text]
  • Exploring the Association Between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: a Vigibase Study
    Drug Safety https://doi.org/10.1007/s40264-018-00789-9 ORIGINAL RESEARCH ARTICLE Exploring the Association between Monoclonal Antibodies and Depression and Suicidal Ideation and Behavior: A VigiBase Study Lotte A. Minnema1,2 · Thijs J. Giezen2,3 · Patrick C. Souverein1 · Toine C. G. Egberts1,4 · Hubert G. M. Leufkens1 · Helga Gardarsdottir1,4,5 © The Author(s) 2019 Abstract Introduction Several monoclonal antibodies (mAbs) have been linked to neuropsychiatric adverse efects in patients, includ- ing depression and suicidal ideation and behavior. Objective The aim of this study was to quantify and characterize spontaneously reported adverse drug reactions (ADRs) of depression and suicidal ideation and behavior related to mAb users, and to explore a possible association with their mecha- nism of action. Methods We included mAb ADRs that were reported in VigiBase, and identifed those related to depression and suicidal ideation and behavior. Reporting odds ratios (RORs) were estimated for each mAb (bevacizumab as the reference) and according to their infuence on the immune system (not directly targeting [reference], stimulating, or suppressing). Those suppressing the immune system were further divided into their intended indication (auto-immune diseases, cancer). Results Overall, 2,924,319 ADRs for 44 mAbs were included; 9455 ADRs were related to depression and 1770 were related to suicidal ideation and behavior. The association was strongest for natalizumab and belimumab, both for depression (ROR 5.7, 95% confdence interval [CI] 5.0–6.4; and ROR 5.1, 95% CI 4.2–6.2) and suicidal ideation and behavior (ROR 12.0, 95% CI 7.9–18.3; and ROR 20.2, 95% CI 12.4–33.0).
    [Show full text]
  • Infliximab, Adalimumab and Golimumab for Treating Moderately
    HEALTH TECHNOLOGY ASSESSMENT VOLUME 20 ISSUE 39 MAY 2016 ISSN 1366-5278 Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model Rachel Archer, Paul Tappenden, Shijie Ren, Marrissa Martyn-St James, Rebecca Harvey, Hasan Basarir, John Stevens, Christopher Carroll, Anna Cantrell, Alan Lobo and Sami Hoque DOI 10.3310/hta20390 Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model Rachel Archer,1* Paul Tappenden,1 Shijie Ren,1 Marrissa Martyn-St James,1 Rebecca Harvey,1 Hasan Basarir,1 John Stevens,1 Christopher Carroll,1 Anna Cantrell,1 Alan Lobo2 and Sami Hoque3 1Health Economics and Decision Science, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK 2Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK 3Barts Health NHS Trust, London, UK *Corresponding author Declared competing interests of authors: none Published May 2016 DOI: 10.3310/hta20390 This report should be referenced as follows: Archer R, Tappenden P, Ren S, Martyn-St James M, Harvey R, Basarir H, et al. Infliximab, adalimumab and golimumab for treating moderately to severely active ulcerative colitis after the failure of conventional therapy (including a review of TA140 and TA262): clinical effectiveness systematic review and economic model. Health Technol Assess 2016;20(39). Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta Medica/EMBASE, Science Citation Index Expanded (SciSearch®) and Current Contents®/ Clinical Medicine.
    [Show full text]
  • Benlysta® (Belimumab)
    UnitedHealthcare Pharmacy Clinical Pharmacy Programs Program Number 2021 P 1227-6 Program Prior Authorization/Notification Medication Benlysta® (belimumab)* *This program applies to the subcutaneous formulation of belimumab P&T Approval Date 9/2017, 9/2018, 9/2019, 9/2020, 2/2021, 7/2021 Effective Date 10/1/2021; Oxford only: 10/1/2021 1. Background: Benlysta® is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of patients aged 5 years and older with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy and adult patients with active lupus nephritis who are receiving standard therapy. Limitations of Use: The efficacy of Benlysta has not been evaluated in patients with severe active central nervous system lupus. Benlysta has not been studied in combination with other biologics. Use of Benlysta is not recommended in these situations. 2. Coverage Criteria: A. Systemic Lupus Erythematosus 1. Initial Authorization a. Benlysta will be approved based on all of the following criteria: (1) Diagnosis of systemic lupus erythematosus -AND- (2) Laboratory testing has documented the presence of autoantibodies [e.g., ANA, Anti-dsDNA, Anti-Sm, Anti-Ro/SSA, Anti-La/SSB] -AND- (3) Patient is currently receiving standard immunosuppressive therapy [e.g., hydroxychloroquine, chloroquine, prednisone, azathioprine, methotrexate] -AND- (4) Patient does not have severe active central nervous system lupus -AND- (5) Patient is not receiving Benlysta in combination with either of the following: (a) Biologic DMARD [e.g., Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Kineret (anakinra)] © 2021 UnitedHealthcare Services, Inc. 1 (b) Lupkynis (voclosporin) Authorization will be issued for 12 months.
    [Show full text]
  • Curriculum Vitae: Daniel J
    CURRICULUM VITAE: DANIEL J. WALLACE, M.D., F.A.C.P., M.A.C.R. Up to date as of January 1, 2019 Personal: Address: 8750 Wilshire Blvd, Suite 350 Beverly Hills, CA 90211 Phone: (310) 652-0010 FAX: (310) 360-6219 E mail: [email protected] Education: University of Southern California, 2/67-6/70, BA Medicine, 1971. University of Southern California, 9/70-6/74, M.D, 1974. Postgraduate Training: 7/74-6/75 Medical Intern, Rhode Island (Brown University) Hospital, Providence, RI. 7/75-6/77 Medical Resident, Cedars-Sinai Medical Center, Los Angeles, CA. 7/77-6/79 Rheumatology Fellow, UCLA School of Medicine, Los Angeles, CA. Medical Boards and Licensure: Diplomate, National Board of Medical Examiners, 1975. Board Certified, American Board of Internal Medicine, 1978. Board Certified, Rheumatology subspecialty, 1982. California License: #G-30533. Present Appointments: Medical Director, Wallace Rheumatic Study Center Attune Health Affiliate, Beverly Hills, CA 90211 Attending Physician, Cedars-Sinai Medical Center, Los Angeles, 1979- Clinical Professor of Medicine, David Geffen School of Medicine at UCLA, 1995- Professor of Medicine, Cedars-Sinai Medical Center, 2012- Expert Reviewer, Medical Board of California, 2007- Associate Director, Rheumatology Fellowship Program, Cedars-Sinai Medical Center, 2010- Board of Governors, Cedars-Sinai Medical Center, 2016- Member, Medical Policy Committee, United Rheumatology, 2017- Honorary Appointments: Fellow, American College of Physicians (FACP) Fellow, American College of Rheumatology (FACR)
    [Show full text]
  • Attachment: Extract from Clinical Evaluation: Etanercept
    AusPAR Attachment 2 Extract from the Clinical Evaluation Report for etanercept Proprietary Product Name: Erelzi Sponsor: Novartis Pharmaceuticals Australia Pty Ltd First round report: June 2017 Second round report: August 2017 Therapeutic Goods Administration About the Therapeutic Goods Administration (TGA) · The Therapeutic Goods Administration (TGA) is part of the Australian Government Department of Health and is responsible for regulating medicines and medical devices. · The TGA administers the Therapeutic Goods Act 1989 (the Act), applying a risk management approach designed to ensure therapeutic goods supplied in Australia meet acceptable standards of quality, safety and efficacy (performance) when necessary. · The work of the TGA is based on applying scientific and clinical expertise to decision- making, to ensure that the benefits to consumers outweigh any risks associated with the use of medicines and medical devices. · The TGA relies on the public, healthcare professionals and industry to report problems with medicines or medical devices. TGA investigates reports received by it to determine any necessary regulatory action. · To report a problem with a medicine or medical device, please see the information on the TGA website <https://www.tga.gov.au>. About AusPARs · An Australian Public Assessment Report (AusPAR) provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve a prescription medicine submission. · AusPARs are prepared and published by the TGA. · An AusPAR is prepared for submissions that relate to new chemical entities, generic medicines, major variations and extensions of indications. · An AusPAR is a static document; it provides information that relates to a submission at a particular point in time.
    [Show full text]
  • Heart Failure and Drug-Induced Lupus
    Unusual toxicities with TNF inhibition: Heart failure and drug-induced lupus J.J. Cush John J. Cush, MD, Chief, Rheumatology ABSTRACT demyelinating disease, cytopenias, auto- and Clinical Immunology, Presbyterian Serious and unexpected adverse events, immune disorders, and heart failure. Hospital of Dallas, Clinical Professor of such as heart failure and drug-induced Other essays in this volume address the Internal Medicine, The University of Texas lupus, have been reported in patients subject of infection (10), demyelination Southwestern Medical School, Dallas, Texas, USA. receiving TNF inhibitor therapy. These (11), and lymphoma (12). This review events generally are easily recogniz- will focus on heart failure and lupus- Please address correspondence to: John J. Cush, MD, Presbyterian Hospital able, although they cannot be predicted like disease, which are rarely seen in of Dallas, 8200 Walnut Hill Lane, Dallas, nor avoided, other than by drug avoid- association with TNF inhibitor therapy Texax 75231-4496, USA. ance altogether. Many patients have and are currently without explanation. Clin Exp Rheumatol 2004; 22 (Suppl. 35): great benefit from anti-TNF therapies. S141-S147. Their intelligent use requires a firm Sources of data © Copyright CLINICAL AND EXPERIMENTAL understanding of these rare toxicities, As a consequence of drug approval, RHEUMATOLOGY 2004. so as to minimize the morbidity associ- manufacturers have a responsibility to ated with their uncommon occurrence. collect safety data actively and report Key words: TNF inhibitors, conges- these data to the appropriate agencies. tive heart failure, drug-induced lupus, Introduction For example, in the USA a manufactur- rheumatoid arthritis. The introduction of biologic agents to er must submit periodic safety reports specifically inhibit the pro-inflammato- to the FDA twice yearly (March and ry cytokine, tumor necrosis factor (TNF), September).
    [Show full text]
  • New Biological Therapies: Introduction to the Basis of the Risk of Infection
    New biological therapies: introduction to the basis of the risk of infection Mario FERNÁNDEZ RUIZ, MD, PhD Unit of Infectious Diseases Hospital Universitario “12 de Octubre”, Madrid ESCMIDInstituto de Investigación eLibraryHospital “12 de Octubre” (i+12) © by author Transparency Declaration Over the last 24 months I have received honoraria for talks on behalf of • Astellas Pharma • Gillead Sciences • Roche • Sanofi • Qiagen Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author Paul Ehrlich (1854-1915) • “side-chain” theory (1897) • receptor-ligand concept (1900) • “magic bullet” theory • foundation for specific chemotherapy (1906) • Nobel Prize in Physiology and Medicine (1908) (together with Metchnikoff) Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author 1981: B-1 antibody (tositumomab) anti-CD20 monoclonal antibody 1997: FDA approval of rituximab for the treatment of relapsed or refractory CD20-positive NHL 2001: FDA approval of imatinib for the treatment of chronic myelogenous leukemia Infections and biologicals: a real concern? (two-hour symposium): New biological therapies: introduction to the ESCMIDbasis of the risk of infection eLibrary © by author Functional classification of targeted (biological) agents • Agents targeting soluble immune effector molecules • Agents targeting cell surface receptors
    [Show full text]