Drug Update for Apr-2021

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1 | P a g eKMCH INSTITUTE OF HEALTH SCIENCES New AND Drug RESEARCH Update (A unit of Kovai Medical Center and Hospital Limited) Coimbatore, Tamil Nadu Department of Pharmacology New Drug Update (New Drugs and Available Drugs with New Formulation) New drugs approved by FDA 1. Idecabtagene vicleucel 2. Dasiglucagon Nothing Worth Having Comes Easy 3. Ponesimod 4. Oritavancin 5. Tivozanib Series - 21 6. Dexmethylphenidate and April 2021 Serdexmethylphenidate Compiled & Edited by: Department of Pharmacology, KMCHIHSR, Coimbatore Kindly Mail Your Suggestions To: [email protected] 2 | P a g e New Drug Update 1. Idecabtagene vicleucel 2. Dasiglucagon Date of Approval: March 26, 2021 Date of Approval: March 22, 2021 Mechanism of action: B-cell Mechanism of action: Glucagon maturation antigen (BCMA)-directed analogue genetically modified autologous Indication: Severe hypoglycemia in chimeric antigen receptor (CAR) T cell diabetes patients aged 6 years and immunotherapy older Indication: Relapsed or refractory Dosage Formulation: Prefilled multiple myeloma autoinjector for subcutaneous injection Dosage Formulation: Intravenous Infusion 3. Ponesimod 4. Oritavancin Date of Approval: March 18, 2021 Date of Approval: March 12, 2021 Mechanism of action: Selective Mechanism of action: Lipoglycopeptide sphingosine-1-phosphate receptor 1 antibiotic acts by inhibiting cell wall (S1P1) modulator synthesis Indication: Relapsing Multiple Indication: Acute bacterial skin and Sclerosis skin structure Infection Dosage Formulation: Tablet Dosage Formulation: Intravenous Infusion 5. Tivozanib 6. Dexmethylphenidate and Serdexmethylphenidate Date of Approval: March 10, 2021 Date of Approval: March 2, 2021 Mechanism of action: Suppresses Mechanism of action: Prodrug of angiogenesis by inhibiting Vascular Methylphenidate acts by blocking the endothelial growth factor receptor reuptake of norepinephrine and (Tyrosine kinase inhibitor) dopamine Indication: Refractory advanced renal Indication: Attention Deficit cell carcinoma Hyperactivity Disorder Dosage Formulation: Capsule Dosage Formulation: Capsule Compiled & Edited by: Department of Pharmacology, KMCHIHSR, Coimbatore Kindly Mail Your Suggestions To: [email protected] .

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Drug Information Center Highlights of FDA Activities
Drug Information Center Highlights of FDA Activities – 3/1/21 – 3/31/21 FDA Drug Safety Communications & Drug Information Updates: Ivermectin Should Not Be Used to Treat or Prevent COVID‐19: MedWatch Update 3/5/21 The FDA advised consumers against the use of ivermectin for the treatment or prevention of COVID‐19 following reports of patients requiring medical support and hospitalization after self‐medicating. Ivermectin has not been approved for this use and is not an anti‐viral drug. Health professionals are encouraged to report adverse events associated with ivermectin to MedWatch. COVID‐19 EUA FAERS Public Dashboard 3/15/21 The FDA launched an update to the FDA Adverse Event Reporting System (FAERS) Public Dashboard that provides weekly updates of adverse event reports submitted to FAERS for drugs and therapeutic biologics used under an Emergency Use Authorization (EUA) during the COVID‐19 public health emergency. Monoclonal Antibody Products for COVID‐19 – Fact Sheets Updated to Address Variants 3/18/21 The FDA authorized revised fact sheets for health care providers to include susceptibility of SARS‐CoV‐2 variants to each of the monoclonal antibody products available through EUA for the treatment of COVID‐19 (bamlanivimab, bamlanivimab and etesevimab, and casirivimab and imdevimab). Abuse and Misuse of the Nasal Decongestant Propylhexedrine Causes Serious Harm 3/25/21 The FDA warned that abuse and misuse of the nasal decongestant propylhexedrine, sold OTC in nasal decongestant inhalers, has been increasingly associated with cardiovascular and mental health problems. The FDA has recommended product design changes to support safe use, such as modifications to preclude tampering and limits on the content within the device.
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Attention-Deficit Hyperactivity Disorder (ADHD) Stimulant Step Therapy
Policy: Attention-Deficit Hyperactivity Disorder (ADHD) Annual Review Date: Stimulant Step Therapy Policy 03/18/2021 Last Revised Date: 06/17/2021 OVERVIEW All of the long-acting stimulants are indicated for the treatment of attention-deficit hyperactivity disorder (ADHD). Some products are also indicated for the treatment of narcolepsy. Vyvanse is the only stimulant medication indicated for the treatment of binge eating disorder (BED). Approval for this indication was based on two 12-week randomized, double- blind, multi-center, parallel-group, placebo-controlled, dose-optimization studies in adults aged 18 to 55 years (n = 374 and n = 350) with moderate to severe BED. Patients from both studies on Vyvanse had a statistically significantly greater reduction from baseline in mean number of binge days/week at Week 12. All of these products have abuse potential and are Schedule II controlled substances. POLICY STATEMENT A step therapy program has been developed to encourage use of one Preferred product prior to the use of a Non-Preferred product. If the step therapy rule is not met for a Non-Preferred agent at the point of service, coverage will be determined by the step therapy criteria below. All approvals are provided for 1 year in duration. Automation: Patients with a history of one Preferred drug within the 130-day look-back period are excluded from step therapy. Preferred Medications: • Generic amphetamine/dextroamphetamine extended-release capsules (generics to Adderall XR) • Generic dexmethylphenidate extended-release capsules (generics
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PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities &
PRODRUG TECHNOLOGY Prodrugs for ADHD Treatments: Opportunities & Potential to Fill Unmet Medical Needs By: Travis Mickle, PhD INTRODUCTION one or more of the ADME categories — Absorption, Distribution, Metabolism, and Excretion — with the goal being the creation of Attention-deficit/hyperactivity disorder (ADHD) is a neuro- a new chemical entity (NCE) that optimizes the performance, util- logical disorder associated with an ongoing pattern of inattention, ity, and potential life-cycle management of the parent drug. hyperactivity, and/or impulsivity that may impede, for example, cognitive and social functioning, and as well as mental growth and development. Since 1937, more than 25 different products ADHD THERAPEUTIC MARKET have been approved by the FDA to treat ADHD. Despite the many pharmacological advances, there is still no optimal treatment of The Centers for Disease Control and Prevention noted in a this condition, leading prescribers and patients to press for im- 2016 report from the National Survey of Children’s Health that provements that address key shortcomings with currently available 6.1 million, or 9.4% of children aged 4 to 17, suffer from ADHD. ADHD medications. Duration of efficacy, consistency of drug ex- Yet, of all children 2 to 17 years of age that may qualify to take posure and effect, onset of action, and lower abuse potential are ADHD medication, only about 317,000 (or 1 in 20) are currently just some of the key attributes that new technologies are seeking being treated. Globally, there are a reported 175 million cases to address. of ADHD in people 5 to 44 years old, and the forecast indicates In the quest for the optimal ADHD medication, leading re- that this number will rise to more than 185 million by 2025.
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Federal Register/Vol. 86, No. 87/Friday, May 7, 2021/Rules And
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Psychiatric Medication Update Objectives Abbreviations
3/30/2021 Psychiatric Medication Update Kara Gagnon, PharmD, BCPS, BCPP Pharmacy & Behavioral Health Programs Manager Objectives Identify newly approved psychiatric medications Discuss medications currently in the pipeline Review pertinent FDA MedWatch Alerts Evaluate new treatment guidelines for schizophrenia Abbreviations ADHD: Attention Deficit Hyperactivity Disorder AP: Antipsychotic CNS: Central Nervous System FDA: Food and Drug Administration FGA: First Generation Antipsychotic SGA: Second Generation Antipsychotic VMAT2: Vesicular monoamine transporter 2 1 3/30/2021 FDA Drug Approval Process ✓ Drug developed ✓ Animals tested ✓ Investigational New Drug (IND) application ✓ Phase 1 → Phase 2 → Phase 3 trials ✓ Review meeting: FDA + drug sponsor ✓ New Drug Application ✓ FDA NDA Review ✓ Drug Labeling ✓ Manufacturer facility inspection ✓ Drug Approval ✓ Post-Marketing monitoring Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download FDA Drug Approval Process Faster Approval Options ➢ Accelerated Approval ➢ Fast Track Prescription Drug User Fee Act (1992) FDA MedWatch ➢ Voluntary system for physicians and consumers to report adverse events Food and Drug Administration. Drug Approval Process. Accessed March 21, 2021. https://www.fda.gov/media/82381/download AzstarysTM (serdexmethylphenidate/dexmethylphenidate) FDA Approval: March 2, 2021 CNS stimulant for treatment of ADHD in patients 6 years of age and older Norepinephrine dopamine reuptake inhibitor; Schedule II substance KemPharm, Inc. ➢ LAT® (Ligand Activated Therapy) technology Azstarys. Package Insert. KemPharm Inc. 2021. 2 3/30/2021 AzstarysTM (serdexmethylphenidate/dexmethylphenidate) Novel once-daily oral capsule ➢ First and only product with dexmethylphenidate prodrug Three strengths available ➢ 26.1mg/5.2mg, 39.2mg/7.8mg, 52.3mg/10.4mg Warnings & Precautions ➢ Abuse/dependence, cardiovascular, psychiatric, growth suppression Azstarys.
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Attention Deficit Hyperactivity Disorder Stimulant Medications
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Psychiatric Medication Update
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Corium Launches Innovative ADHD Treatment AZSTARYSTM (Serdexmethylphenidate and Dexmethylphenidate) in the U.S
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U.S. Food and Drug Administration Approves Novel Once-Daily Capsule AZSTARYSTM (Serdexmethylphenidate and Dexmethylphenidate), F
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ADHD Narcolepsy
ADHD Narcolepsy Override(s) Approval Duration Prior Authorization 1 year Quantity Limit Quantity Limit All agents May be subject to quantity limit Medications Preferred Products Atomoxetine: Strattera generic Clonidine (extended release): Kapvay generic Dexmethylphenidate: Focalin generic Focalin XR generic Dextroamphetamine and Amphetamine: Adderall generic Adderall XR generic Dextroamphetamine: Dexedrine tablet generic Dexedrine capsules generic Methylphenidate: Metadate ER generic methylphenidate products, except: chewable tablets and ER 72mg tablets Non-Preferred Products Atomoxetine: Strattera Brand Amphetamine: Dyanavel XR Adzenys ER Suspension (and generic) Adzenys XR-ODT PAGE 1 of 9 07/20/2021 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare. Note that market specific restrictions or transition-of-care benefit limitations may apply. CRX-ALL-0716-21 Market Applicability Market GA MD NJ NY Applicable X NA X X Clonidine (extended release): Kapvay Brand Guanfacine (extended release): Intuniv and generic Dextroamphetamine and Amphetamine: Adderall Brand Adderall XR Brand Mydayis ER Dextroamphetamine: Dexedrine spansules Brand Dexmethylphenidate: Focalin Brand Focalin XR Brand Transdermal Methylphenidate: Daytrana Dextroamphetamine: ProCentra solution (and generic) Zenzedi Brand Methylphenidate: Adhansia XR Aptensio XR (and generic) Concerta Brand Cotempla XR - ODT Jornay PM Metadate CD Brand Methylin Brand Methylin ER Brand Methylphenidate chewable tablets Methylphenidate ER 72mg tablets Relexxii ER 72mg tablets Ritalin Brand Ritalin LA Brand Quillichew ER Brand Quillivant XR Brand Serdexmethylphenidate and Dexmethylphenidate: Azstarys PAGE 2 of 9 07/20/2021 This policy does not apply to health plans or member categories that do not have pharmacy benefits, nor does it apply to Medicare.
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D Rug U Tilization R Eview B Oard
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