Clinical News: April 2024

April 25, 2024

Your monthly source for drug information highlights

Clinical News

Your monthly source for drug information highlights

Hot topic

NEW PRESCRIPTION DIGITAL THERAPEUTIC FOR DEPRESSION

The U.S. Food and Drug Administration (FDA) has cleared for marketing Rejoyn, the first prescription digital therapeutic authorized for the adjunctive treatment of major depressive disorder (MDD) symptoms. Rejoyn is a prescription digital therapeutic phone app used as an adjunct to clinician-managed outpatient care for adults ≥ 22 years old who are on antidepressant medication. The app provides a six-week program of (1) Cognitive Behavioral Therapy (CBT)–based lessons, (2) Emotional Faces Memory Task (EFMT) exercises, and (3) personalized reminders and messaging. The CBT lessons can be repeated for an additional four weeks, after which the patient will not have access. Clearance was based on data from a 13-week, double-blinded, randomized controlled study conducted in 386 patients 22 to 64 years of age with a diagnosis of MDD who were receiving an antidepressant. An improvement in depression symptom severity from baseline was demonstrated across multiple patient- and clinician-reported scales. The app is a medical device and will be available for download on the App Store® or Google Play™ in the summer of 2024. An access code will be required to unlock treatment and will be provided by the dispensing pharmacy. Additional information is available in the Clinician Brief Summary.

More trending topics

WEIGHT MANAGEMENT CORNER

The FDA has approved 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg single-dose vials of tirzepatide (Zepbound), a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. The agent is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥ 30 kg/m2 or of ≥ 27 kg/m2 in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus [T2DM], obstructive sleep apnea, cardiovascular disease). Zepbound was already approved in 0.5 mL single-dose pens in all strengths.

The FDA is currently reporting shortages of GLP-1 agonists that are indicated for select patients as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management. This includes liraglutide (Saxenda), which has limited availability due to increased demand. The 2.5 mg/0.5 mL strength of tirzepatide (Zepbound) is currently available, all other strengths have limited availability through Q2 2024 due to increased demand for the drug.

Shortages are also being reported for GLP-1 agonists that are indicated for select patients with T2DM. Liraglutide (Victoza) has limited availability through June 2024 due to delays in shipping. Additionally, tirzepatide (Mounjaro) in the 2.5 mg/0.5 mL is currently available, all other strengths have limited availability through Q2 2024 due to increased demand.

BEHAVIORAL HEALTH CORNER

Shortages of stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) are currently being reported. These include generic methylphenidate HCl extended-release (ER) tablets, as well as generic lisdexamfetamine dimesylate capsules and chewable tablets. Shortages of generic amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate immediate release (IR) tablets also continue from select manufacturers.

BIOSIMILAR CORNER

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has finalized contract year 2025 changes enhancing the flexibility of Medicare Part D plans to substitute lower cost biosimilars for their reference products. Specifically, the final rule allows for all biosimilars to be substituted as formulary maintenance changes that would not require explicit prior approval from CMS. Previously, only interchangeable biosimilars were eligible for substitution as a “maintenance change.” Allowing for all biosimilar substitutions to be treated as maintenance changes ensures that midyear formulary substitution of biosimilars for their reference products applies to all enrollees (following a 30-day advance notice), including patients who are already receiving a reference product before the effective date of change. Prior to this change, Part D sponsors were required to obtain approval before substituting a biosimilar for a reference product if the biosimilar was not an interchangeable biosimilar. As a result, these substitutions were only applicable to enrollees who initiated therapy after the effective date of change. Furthermore, the contract year 2025 final rule allows for new interchangeable biological products to be immediately substituted on the formulary. This would apply to interchangeable biosimilars not commercially available at the time of initial formulary submission for CMS approval. Sponsors who have met certain requirements will have the option to immediately substitute new interchangeable biosimilars for a reference product, with impacted enrollees notified of the change after it has been enacted.

WEIGHT MANAGEMENT CORNER

The FDA has approved 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg single-dose vials of tirzepatide (Zepbound), a dual glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist. The agent is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of ≥ 30 kg/m2 or of ≥ 27 kg/m2 in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus [T2DM], obstructive sleep apnea, cardiovascular disease). Zepbound was already approved in 0.5 mL single-dose pens in all strengths.

The FDA is currently reporting shortages of GLP-1 agonists that are indicated for select patients as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management. This includes liraglutide (Saxenda), which has limited availability due to increased demand. The 2.5 mg/0.5 mL strength of tirzepatide (Zepbound) is currently available, all other strengths have limited availability through Q2 2024 due to increased demand for the drug.

Shortages are also being reported for GLP-1 agonists that are indicated for select patients with T2DM. Liraglutide (Victoza) has limited availability through June 2024 due to delays in shipping. Additionally, tirzepatide (Mounjaro) in the 2.5 mg/0.5 mL is currently available, all other strengths have limited availability through Q2 2024 due to increased demand.

BEHAVIORAL HEALTH CORNER

Shortages of stimulants for the treatment of attention-deficit/hyperactivity disorder (ADHD) are currently being reported. These include generic methylphenidate HCl extended-release (ER) tablets, as well as generic lisdexamfetamine dimesylate capsules and chewable tablets. Shortages of generic amphetamine aspartate monohydrate, amphetamine sulfate, dextroamphetamine saccharate and dextroamphetamine sulfate immediate release (IR) tablets also continue from select manufacturers.

BIOSIMILAR CORNER

The U.S. Department of Health and Human Services (HHS), through the Centers for Medicare & Medicaid Services (CMS), has finalized contract year 2025 changes enhancing the flexibility of Medicare Part D plans to substitute lower cost biosimilars for their reference products. Specifically, the final rule allows for all biosimilars to be substituted as formulary maintenance changes that would not require explicit prior approval from CMS. Previously, only interchangeable biosimilars were eligible for substitution as a “maintenance change.” Allowing for all biosimilar substitutions to be treated as maintenance changes ensures that midyear formulary substitution of biosimilars for their reference products applies to all enrollees (following a 30-day advance notice), including patients who are already receiving a reference product before the effective date of change. Prior to this change, Part D sponsors were required to obtain approval before substituting a biosimilar for a reference product if the biosimilar was not an interchangeable biosimilar. As a result, these substitutions were only applicable to enrollees who initiated therapy after the effective date of change. Furthermore, the contract year 2025 final rule allows for new interchangeable biological products to be immediately substituted on the formulary. This would apply to interchangeable biosimilars not commercially available at the time of initial formulary submission for CMS approval. Sponsors who have met certain requirements will have the option to immediately substitute new interchangeable biosimilars for a reference product, with impacted enrollees notified of the change after it has been enacted.

Drug information happenings & highlights

DRUG INFORMATION HIGHLIGHTS

  • Amylyx, the manufacturer of sodium phenylbutyrate and taurursodiol oral suspension (Relyvrio), has initiated the process with the FDA to voluntarily discontinue marketing authorization of Relyvrio in the U.S. based on results from the phase 3 PHOENIX study. Relyvrio was indicated for the treatment of amyotrophic lateral sclerosis (ALS) in adults. As of April 4, 2024, Relyvrio is no longer available for new patients; however, patients currently receiving the medication who, in consultation with their HCP, would like to continue therapy, are eligible to be transitioned to a free drug program.
  • Avkare has voluntarily recalled one lot of atovaquone oral suspension, USP 750 mg/5 mL to the consumer level due to the potential for Bacillus cereus contamination. Microbial contamination was identified during stability testing and could lead to disseminated, life-threatening infections, such as endocarditis or necrotizing soft tissue infections, in immunocompromised patients.
  • Amneal has voluntarily recalled four lots of vancomycin HCl for oral solution, USP, 250 mg/5 mL to the consumer level as some bottles may have been overfilled, which can result in an excess dose. Based on the maximum daily dose of 2 g/day, patients with a dosing regimen of 500 mg/10 mL would exceed the daily maximum dose, which could be harmful in those with renal insufficiency. The four recalled lots are packaged in 80 mL, 150 mL, or 300 mL sizes.
  • Pfizer has announced discontinuation of manufacturing of linezolid (Zyvox) 600 mg tablet. The oral suspension formulation of Zyvox remains commercially available.
  • Eli Lilly has announced discontinuation of the 3 mL vial of insulin lispro (Humalog). The 10 mL vials and KwikPen presentations of Humalog and insulin lispro injection remain available.
  • The FDA has reported that Genentech will be discontinuing distribution of somatropin (Nutropin AQ) injection 5 mg/2 mL, 10 mg/2 mL, and 20 mg/2 mL. This is a business decision based on the availability of generic and alternative treatments.

DRUG INFORMATION HAPPENINGS

  • The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) concluded that current evidence does not demonstrate a causal association between GLP-1 agonists and suicidal thoughts or actions. However, manufacturers of GLP-1 agonists will monitor for these safety signals and report any new evidence.
  • The American Society of Clinical Oncology (ASCO) has published a guideline update on systemic therapy for advanced hepatocellular carcinoma. The evidence-based guideline provides an update to the 2020 version and includes data from 10 new randomized controlled trials.
  • The American Society of Health-System Pharmacists (ASHP) has published a summary of national drug shortage statistics from January 2001 to March 2024. Since data tracking began in 2001, current and ongoing shortages are the highest number reported on record at 323 drug shortages.
  • The Centers for Disease Control and Prevention (CDC) is investigating Botox products that have led to harmful reactions. As of mid-April, 19 people in nine states have experienced these reactions following receipt of counterfeit product or injections administered by unlicensed individuals and/or administered in a non-health care setting (e.g., spas, homes); nine of these individuals were hospitalized and four of them were treated with botulism antitoxin due to symptoms consistent with toxin spread.

The content in this publication is not a substitute for professional medical advice. For questions regarding any medical condition or if you need medical advice, please contact your health care provider.

All brand names are property of their respective owners.

Glossary

HCl = hydrochloride

HCP = health care professional

USP = U.S. Pharmacopeia

Editorial team

EDITOR-IN-CHIEF: Maryam Tabatabai, PharmD

EXECUTIVE EDITOR: Anna Schreck Bird, PharmD

DEPUTY EDITORS: Erik Hamel, PharmD; Olivia Pane, PharmD, CDCES

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