Where Do Novel Drugs of 2016 Fit In?
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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. -
Fig. L COMPOSITIONS and METHODS to INHIBIT STEM CELL and PROGENITOR CELL BINDING to LYMPHOID TISSUE and for REGENERATING GERMINAL CENTERS in LYMPHATIC TISSUES
(12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date Χ 23 February 2012 (23.02.2012) WO 2U12/U24519ft ft A2 (51) International Patent Classification: AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, A61K 31/00 (2006.01) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, (21) International Application Number: HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, PCT/US201 1/048297 KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, (22) International Filing Date: ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, 18 August 201 1 (18.08.201 1) NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, (25) Filing Language: English TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, ZM, (26) Publication Language: English ZW. (30) Priority Data: (84) Designated States (unless otherwise indicated, for every 61/374,943 18 August 2010 (18.08.2010) US kind of regional protection available): ARIPO (BW, GH, 61/441,485 10 February 201 1 (10.02.201 1) US GM, KE, LR, LS, MW, MZ, NA, SD, SL, SZ, TZ, UG, 61/449,372 4 March 201 1 (04.03.201 1) US ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, DE, DK, (72) Inventor; and EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, ΓΓ, LT, LU, (71) Applicant : DEISHER, Theresa [US/US]; 1420 Fifth LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, Avenue, Seattle, WA 98101 (US). -
Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients
antibodies Review Pharmacologic Considerations in the Disposition of Antibodies and Antibody-Drug Conjugates in Preclinical Models and in Patients Andrew T. Lucas 1,2,3,*, Ryan Robinson 3, Allison N. Schorzman 2, Joseph A. Piscitelli 1, Juan F. Razo 1 and William C. Zamboni 1,2,3 1 University of North Carolina (UNC), Eshelman School of Pharmacy, Chapel Hill, NC 27599, USA; [email protected] (J.A.P.); [email protected] (J.F.R.); [email protected] (W.C.Z.) 2 Division of Pharmacotherapy and Experimental Therapeutics, UNC Eshelman School of Pharmacy, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] 3 Lineberger Comprehensive Cancer Center, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599, USA; [email protected] * Correspondence: [email protected]; Tel.: +1-919-966-5242; Fax: +1-919-966-5863 Received: 30 November 2018; Accepted: 22 December 2018; Published: 1 January 2019 Abstract: The rapid advancement in the development of therapeutic proteins, including monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs), has created a novel mechanism to selectively deliver highly potent cytotoxic agents in the treatment of cancer. These agents provide numerous benefits compared to traditional small molecule drugs, though their clinical use still requires optimization. The pharmacology of mAbs/ADCs is complex and because ADCs are comprised of multiple components, individual agent characteristics and patient variables can affect their disposition. To further improve the clinical use and rational development of these agents, it is imperative to comprehend the complex mechanisms employed by antibody-based agents in traversing numerous biological barriers and how agent/patient factors affect tumor delivery, toxicities, efficacy, and ultimately, biodistribution. -
Predictive QSAR Tools to Aid in Early Process Development of Monoclonal Antibodies
Predictive QSAR tools to aid in early process development of monoclonal antibodies John Micael Andreas Karlberg Published work submitted to Newcastle University for the degree of Doctor of Philosophy in the School of Engineering November 2019 Abstract Monoclonal antibodies (mAbs) have become one of the fastest growing markets for diagnostic and therapeutic treatments over the last 30 years with a global sales revenue around $89 billion reported in 2017. A popular framework widely used in pharmaceutical industries for designing manufacturing processes for mAbs is Quality by Design (QbD) due to providing a structured and systematic approach in investigation and screening process parameters that might influence the product quality. However, due to the large number of product quality attributes (CQAs) and process parameters that exist in an mAb process platform, extensive investigation is needed to characterise their impact on the product quality which makes the process development costly and time consuming. There is thus an urgent need for methods and tools that can be used for early risk-based selection of critical product properties and process factors to reduce the number of potential factors that have to be investigated, thereby aiding in speeding up the process development and reduce costs. In this study, a framework for predictive model development based on Quantitative Structure- Activity Relationship (QSAR) modelling was developed to link structural features and properties of mAbs to Hydrophobic Interaction Chromatography (HIC) retention times and expressed mAb yield from HEK cells. Model development was based on a structured approach for incremental model refinement and evaluation that aided in increasing model performance until becoming acceptable in accordance to the OECD guidelines for QSAR models. -
Review Anti-Cytokine Biologic Treatment Beyond Anti-TNF in Behçet's Disease
Review Anti-cytokine biologic treatment beyond anti-TNF in Behçet’s disease A. Arida, P.P. Sfikakis First Department of Propedeutic Internal ABSTRACT and thrombotic complications (1-3). Medicine Laikon Hospital, Athens, Unmet therapeutic needs in Behçet’s Treatment varies according to type and University Medical School, Greece. disease have drawn recent attention to severity of disease manifestations. Cor- Aikaterini Arida, MD biological agents targeting cytokines ticosteroids, interferon-alpha and con- Petros P. Sfikakis, MD other than TNF. The anti-IL-17 anti- ventional immunosuppressive drugs, Please address correspondence to: body secukinumab and the anti-IL-2 such as azathioprine, cyclosporine-A, Petros P. Sfikakis, MD, receptor antibody daclizumab were not cyclophosphamide and methotrexate, First Department of Propedeutic superior to placebo for ocular Behçet’s and Internal Medicine, are used either alone or in combination Laikon Hospital, in randomised controlled trials, com- for vital organ involvement. During the Athens University Medical School, prising 118 and 17 patients, respec- last decade there has been increased use Ag Thoma, 17, tively. The anti-IL-1 agents anakinra of anti-TNF monoclonal antibodies in GR-11527 Athens, Greece. and canakinumab and the anti-IL-6 patients with BD who were refractory E-mail: [email protected] agent tocilizumab were given to iso- to conventional treatment or developed Received on June 7, 2014; accepted in lated refractory disease patients, who life-threatening complications (4, 5). revised form on September 17, 2014. were either anti-TNF naïve (n=9) or Anti-TNF treatment has been shown to Clin Exp Rheumatol 2014; 32 (Suppl. 84): experienced (n=18). -
Tocilizumab in the Treatment of Severe and Refractory Parenchymal Neuro
TAB0010.1177/1759720X20971908Therapeutic Advances in Musculoskeletal DiseaseJ Liu, D Yan 971908research-article20202020 Therapeutic Advances in Musculoskeletal Disease Case Series Ther Adv Musculoskel Dis Tocilizumab in the treatment of severe and 2020, Vol. 12: 1–8 DOI:https://doi.org/10.1177/1759720X20971908 10.1177/ refractory parenchymal neuro-Behçet’s 1759720X20971908https://doi.org/10.1177/1759720X20971908 © The Author(s), 2020. Article reuse guidelines: syndrome: case series and literature review sagepub.com/journals- permissions Jinjing Liu* , Dong Yan*, Zhimian Wang, Yunjiao Yang, Shangzhu Zhang, Di Wu, Lingyi Peng, Zhichun Liu and Wenjie Zheng Abstract Correspondence to: Objectives: This study aimed to investigate the efficacy and safety of tocilizumab (TCZ) in Wenjie Zheng severe and refractory parenchymal neuro-Behçet’s syndrome (p-NBS). Department of Rheumatology and Clinical Methods: We retrospectively analyzed five patients with p-NBS treated with TCZ in our center Immunology, Peking Union between 2013 and 2020, and six cases from literature research with the index terms “neuro- Medical College Hospital, Chinese Academy of Behçet’s syndrome” and “tocilizumab” on PubMed NCBI. Medical Sciences & Peking Union Medical Results: A total of 11 patients with p-NBS were enrolled (5 males, 6 females), with a mean College, Key Laboratory of age of 34.5 ± 8.0 years at the onset. All the patients had parenchymal neurological lesions, Rheumatology and Clinical Rheumatology, Ministry six patients (54.5%) suffered from multiple lesions, and nine patients (81.8%) were disabled. of Education, National Clinical Research Center Before TCZ administration, all the patients had failed conventional therapy, eight patients for Dermatologic and (72.7%) received two or more immunosuppressants, and five patients showed insufficient Immunologic Diseases, No. -
Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products. -
Inflammatory Conditions – Kevzara™ (Sarilumab for Subcutaneous Injection)
Cigna National Formulary Coverage Policy Prior Authorization Inflammatory Conditions – Kevzara® (sarilumab for subcutaneous injection) Table of Contents Product Identifier(s) National Formulary Medical Necessity ................ 1 59231 Conditions Not Covered....................................... 2 Background .......................................................... 2 References .......................................................... 3 Revision History ................................................... 3 INSTRUCTIONS FOR USE The following Coverage Policy applies to health benefit plans administered by Cigna Companies. Certain Cigna Companies and/or lines of business only provide utilization review services to clients and do not make coverage determinations. References to standard benefit plan language and coverage determinations do not apply to those clients. Coverage Policies are intended to provide guidance in interpreting certain standard benefit plans administered by Cigna Companies. Please note, the terms of a customer’s particular benefit plan document [Group Service Agreement, Evidence of Coverage, Certificate of Coverage, Summary Plan Description (SPD) or similar plan document] may differ significantly from the standard benefit plans upon which these Coverage Policies are based. For example, a customer’s benefit plan document may contain a specific exclusion related to a topic addressed in a Coverage Policy. In the event of a conflict, a customer’s benefit plan document always supersedes the information in the Coverage Policies. In the absence of a controlling federal or state coverage mandate, benefits are ultimately determined by the terms of the applicable benefit plan document. Coverage determinations in each specific instance require consideration of 1) the terms of the applicable benefit plan document in effect on the date of service; 2) any applicable laws/regulations; 3) any relevant collateral source materials including Coverage Policies and; 4) the specific facts of the particular situation. -
As a Group, Anti- Inflammatories Will
THERAPEUTIC FOCUS Sandoz’s Zarxio in March opened the door The inflammatory disease space exalts the for an established regulatory pathway here. approval of moderate-to-severe plaque Zarxio is biosimilar to Amgen’s neutrope- psoriasis treatment Cosentyx (secukinu- nia drug Neupogen (filgrastim), originally mab). “This is the first drug in the last 10 licensed in 1991. years with published studies showing clear According to Lindqvist, the US entry of superiority to the current standard of treat- biosimilars will dent the sales of a number ment,” observes Marcin Ernst, MD, VP of of individual branded biologic franchises, clinical development at INC Research (see Autoimmune but the impact is likely to pale in compari- “Clinical Corner,” p. 52). son to the generic competition for “white Eli Lilly’s ixekizumab and AstraZeneca/ pill” small-molecule drugs. Looking ahead, “As a group, anti- Amgen’s brodalumab, both of which target Biosimilars are threatening to chip away at established blockbusters. Industry giants are N+1 Singer analysts believe the biolog- inflammatories will the IL-17A cytokine, are expected to elbow battling to devise better therapies for celiac, Crohn’s and lupus even as they work around ics market will reach about $300 billion in their way into the picture. Both companies annual global sales by 2020, including about continue to top the plan regulatory submissions for psoriasis the clock to protect their turf in RA and psoriasis. Welcome to the autoimmune category— $50 billion from biosimilars. best-selling drug list. this year. in which, Rebecca Mayer Knutsen explains, there’s never a dull moment But the regulatory pathway for biosimilars These drugs are high- A few companies are jockeying to bring is murky, Buthusiem says. -
New Biologics in Psoriasis: an Update on IL-23 and IL-17 Inhibitors
New Biologics in Psoriasis: An Update on IL-23 and IL-17 Inhibitors Joanna Dong, BA; Gary Goldenberg, MD PRACTICE POINTS • The newest biologics for treatment of moderate to severe plaque psoriasis are IL-23 and IL-17 inhibitors with unprecedented efficacy of complete skin clearance compared to older biologics. • Risankizumab, guselkumab, and tildrakizumab are new IL-23 inhibitors currently in phase 3 trials with promising early efficacy and safety results. • Ixekizumab, which recently was approved, and brodalumab, which is pending US Food and Drug Administration review, are new IL-17 inhibitors that achieved total skin clearance in more than one-quarter of phase 3 participants after 12 weeks of treatment. copy not As immune-related pathways involved in the he role of current biologic therapies in pso- pathogenesis of psoriasis are elucidated, new riasis predicates on the pathogenic role of biologic treatments targeting these steps of the Tupregulated, immune-related mechanisms psoriatic immune cascade are developed. In Dothis that result in the activation of myeloid dendritic article, we review the literature on IL-23 and IL-17 cells, which release IL-17, IL-23, and other cytokines inhibitors in the pipeline for use in moderate to to activate T cells, including helper T cell TH17. severe psoriasis. Numerous pipeline biologic Along with other immune cells, TH17 produces therapies, including risankizumab, guselkumab, IL-17. This proinflammatory cascade results in kera- tildrakizumab, ixekizumab, and brodalumab, are tinocyte proliferation, angiogenesis, and migration being investigated in phase 2 and 3 studies to of immune cells toward psoriatic lesions.1 Thus, the establish the efficacy and safety of these new newest classes of biologics target IL-12, IL-23, and agents. -
Bezlotoxumab (Zinplava®)
Zinplava Swiss Risk Management Plan Summary V1.5 Swiss Summary of the Risk Management Plan (RMP) for Zinplava® (Bezlotoxumab 1000mg) Concentrate for solution for infusion Version 1.5 (November 2016) The Risk Management Plan (RMP) is a comprehensive document submitted as part of the application dossier for market approval of a medicine. The RMP summary contains information on the medicine's safety profile and explains the measures that are taken in order to further investigate and follow the risks as well as to prevent or minimise them. The RMP summary of Zinplava® is a concise document and does not claim to be exhaustive. As the RMP is an international document, the summary might differ from the “Arzneimittelinformation / Information sur le médicament” approved and published in Switzerland, e.g. by mentioning risks occurring in populations or indications not included in the Swiss authorisation. Please note that the reference document which is valid and relevant for the effective and safe use of Zinplava® in Switzerland is the “Arzneimittelinformation / Information sur le médicament” (see www.swissmedicinfo.ch) approved and authorized by Swissmedic. MSD Merck Sharp & Dohme AG is fully responsible for the accuracy and correctness of the content of the published summary RMP of Zinplava®. Zinplava Swiss Risk Management Plan Summary V1.5 1 Elements for Summary Tables in the EPAR 1.1 Summary Table of Safety Concerns Table 1 Summary of Safety Concerns Important identified risks None Important potential risks Infusion-related Reactions Including -
Asthma Agents
APPROVED PA Criteria Initial Approval Date: July 10, 2019 Revised Date: January 20, 2021 CRITERIA FOR PRIOR AUTHORIZATION Asthma Agents BILLING CODE TYPE For drug coverage and provider type information, see the KMAP Reference Codes webpage. MANUAL GUIDELINES Prior authorization will be required for all current and future dose forms available. All medication-specific criteria, including drug-specific indication, age, and dose for each agent is defined in Table 1 below. Benralizumab (Fasenra®) Dupilumab (Dupixent®) Mepolizumab (Nucala®) Omalizumab (Xolair®) Reslizumab (Cinqair®) GENERAL CRITERIA FOR INITIAL PRIOR AUTHORIZATION: (must meet all of the following) • Must be approved for the indication, age, and not exceed dosing limits listed in Table 1. • Must be prescribed by or in consultation with a pulmonologist, allergist, or immunologist.1,2 • For all agents listed, the preferred PDL drug, which treats the PA indication, is required unless the patient meets the non-preferred PDL PA criteria. • Must have experienced ≥ 2 exacerbations within the last 12 months despite meeting all of the following (exacerbation is defined as requiring the use of oral/systemic corticosteroids, urgent care/hospital admission, or intubation: o Patient adherence to two long-term controller medications, including a high-dose inhaled corticosteroid 1,2 (ICS) and a long-acting beta2-agonist (LABA) listed in Table 2. ▪ Combination ICS/LABA and ICS/LABA/LAMA products meet the requirement of two controller medications. o Patient must have had an adequate trial (at least 90 consecutive days) of a leukotriene modifier or a long-acting muscarinic antagonist (LAMA) as a third long-term controller medication listed in Table 2.