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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 5 | Issue 19
November 1, 2023

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Bimzelx® for Moderate to Severe Plaque Psoriasis in Adults

On October 18, 2023, the U.S. Food and Drug Administration (FDA) approved Bimzelx® (bimekizumab-bkzx) for the treatment of adults with moderate to severe plaque psoriasis. Plaque psoriasis is a chronic autoimmune disease that causes thick, scaly patches on the skin. This disorder affects 7.5 million adults in the U.S. Bimzelx® is the first monoclonal antibody that selectively inhibits interleukin (IL)-17A and IL-17F, two key factors that drive inflammation. It will be available as a single-dose prefilled autoinjector and a single-dose prefilled syringe, and it can be injected by a healthcare provider or self-administered. In a phase 3, controlled trial, 478 patients were randomized to receive either Bimzelx® or adalimumab. At week 16, 86.2% of patients in the Bimzelx® group reported a 90% or greater reduction in the Psoriasis Area and Severity Index (PASI) score compared to 47.2% in the adalimumab group. The most common adverse effects with Bimzelx® include upper respiratory tract infection, oral yeast infection, headache, ear infection, acne, fatigue and injection site reactions. It is anticipated that Bimzelx® will be available by the end of 2023.  

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Drug Safety

KVK-Tech, Inc. Issues Voluntary Nationwide Recall of One Lot of Betaxolol Tablets

On September 29, 2023, KVK-Tech announced a voluntary recall of betaxolol 10 mg tablets as a precautionary measure. A single oxycodone 5 mg foreign tablet was found on the packaging line after the recalled batch was packaged. It is unknown if any oxycodone tablets were introduced into any of the affected bottles of betaxolol. There are only minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, and patients may not notice these differences if they are contained in the same bottle. Inadvertent exposure to an opioid such as oxycodone can lead to significantly slowed breathing and heart rate, especially in older adults, infants, children and persons with opioid use disorder (OUD). Missed doses of betaxolol could worsen heart and lung function. Betaxolol 10 mg tablets are white, round, film-coated biconvex tablets, debossed with a “K” above the bisect scoring line and “13” below the line and are plain on the other side.

The recalled lot has an associated lot number of 17853A and expiration date of June 2027. It was distributed nationwide to wholesalers and retailers. KVK sent letters to distributors and customers on 09/26/23, and they are arranging for the return of the recalled lot. Additionally, consumers with bottles of the recalled lot should stop using and immediately return the product. To date, there have been no reports of adverse events associated with this recall.  Patients experiencing any adverse events related to the product are advised to contact their physician or health care provider and to report the event to the FDA’s MedWatch Adverse Event Reporting Program.

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From the Pharmaceutical Industry

FDA Authorizes Updated Novavax COVID-19 Vaccine

On October 3, 2023, the FDA announced an update to the emergency use authorization of the Novavax COVID-19 vaccine. Novavax is a monovalent vaccine, meaning it targets one strain of the virus. It has been updated to include the spike protein from the omicron variant lineage to provide stronger protection against currently circulating variants of the disease. The original Novavax COVID-19 vaccination is no longer authorized for use in the United States and has been replaced with this new 2023-2024 updated formula. Data to support this approval was accumulated from non-clinical immune response data against the currently circulating COVID-19 variants, and safety and effectiveness data from clinical trials of the original Novavax COVID-19 vaccine, investigational monovalent and bivalent COVID-19 vaccines and post-marketing data. Individuals 12 years and older are encouraged to receive the updated COVID-19 vaccine to protect themselves as rates of COVID-19 and influenza viruses are expected to rise. Immunocompromised individuals are also highly encouraged to get vaccinated. Unvaccinated individuals will receive two doses of the vaccine while those who are vaccinated with a previous COVID-19 vaccine will only require one dose. Side effects may include injection site reaction, sore arm and flu-like symptoms.

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FDA Approvals

New FDA Approvals

New Drug: VelsipityTM (etrasimod) 

Oral tablet approved for the treatment of moderately to severely active ulcerative colitis in adult patients. [10/12/2023 – PFIZER]

New Drug: Cosentyx® (secukinumab)

Intravenous infusion approved for the treatment of adults with active psoriatic arthritis, ankylosing spondylitis or non-radiographic axial spondyloarthritis with objective signs of inflammation. [10/06/2023 – NOVARTIS]

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New Generics

New Generics Entering the Marketplace

Mydayis®  (dextroamphetamine sulfate, dextroamphetamine saccharate, amphetamine aspartate monohydrate and amphetamine sulfate)

Indication: Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 13 years and older.

Dosage Form/Strength: 12.5mg, 25mg, 37.5mg and 50mg extended-release capsules

Average Wholesale Price (AWP): Generic = $386 | Brand = $407