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Clinical Insights: October 25, 2023

Posted on October 25, 2023 By RxStrategies, Inc. -

Welcome to RxStrategies’ Clinical Insights, designed to help pharmacy professionals stay up to date on the ever-changing pharmaceutical and pharmacy marketplace. Contact us to learn more.

New Drug/Vaccine Approval

Penbraya (meningococcal groups A, B, C, W, and Y vaccine) Injection – New Vaccine Approval – October 20, 2023 – Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration (FDA) has approved Penbraya™ (meningococcal groups A, B, C, W and Y vaccine), the first and only pentavalent vaccine that provides coverage against the most common serogroups causing meningococcal disease in adolescents and young adults 10 through 25 years of age. Penbraya™ combines the components from two meningococcal vaccines, Trumenba® (meningococcal group B vaccine) and Nimenrix® (meningococcal groups A, C, W-135, and Y conjugate vaccine) to help protect against the five most common meningococcal serogroups that cause the majority of invasive meningococcal disease (IMD) globally. <Read More>

Cabtreo™ (adapalene, benzoyl peroxide and clindamycin phosphate) Topical Gel – New Drug Approval – October 20, 2023 – Bausch Health Companies Inc. (NYSE/TSX: BHC) (“Bausch Health”) and its dermatology business, Ortho Dermatologics, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for Cabtreo™ (clindamycin phosphate, adapalene and benzoyl peroxide) Topical Gel 1.2%/0.15%/3.1%, indicated for the topical treatment of acne vulgaris in patients twelve years of age and older. Cabtreo™ is the first and only FDA-approved fixed-dose, triple-combination topical treatment for acne. Cabtreo™ is expected to be available to patients in Q1 2024. <Read More>

Zilbrysq® (zilucoplan) Injection – New Drug Approval – October 17, 2023 – UCB (Euronext Brussels: UCB), a global biopharmaceutical company, announced that Zilbrysq® (zilucoplan) has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody-positive. Zilbrysq® is the first once-daily subcutaneous, targeted peptide inhibitor of complement component 5 (C5 inhibitor)2. It is the only once-daily gMG target therapy for self-administration by adult patients with anti-AChR antibody-positive gMG. <Read More>

Xphozah® (tenapanor) Tablets – New Drug Approval – October 17, 2023 – Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, announced that the U.S. Food and Drug Administration (FDA) has approved Xphozah® (tenapanor), the first and only phosphate absorption inhibitor, indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. Xphozah® is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway. <Read More>

Qlosi™ (pilocarpine hydrochloride) Ophthalmic Solution – New Drug Approval –October 17, 2023 – Orasis Pharmaceuticals, an emerging ophthalmic pharmaceutical company focused on reshaping vision possibilities, announced that the U.S. Food and Drug Administration (FDA) has approved Qlosi™ (pilocarpine hydrochloride ophthalmic solution) 0.4% for the treatment of presbyopia in adults. Qlosi™ is expected to be commercially available in the U.S. in the first half of 2024. <Read More>

Bimzelx® (bimekizumab-bkzx) Injection – New Drug Approval –October 17, 2023 – UCB, a global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has approved Bimzelx® (bimekizumab-bkzx) for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.  Bimekizumab is the first and only approved psoriasis treatment designed to selectively inhibit two key cytokines driving inflammatory processes – interleukin 17A (IL-17A) and interleukin 17F (IL-17F).1 The approval of bimekizumab is supported by data from three Phase 3, multicenter, randomized, placebo and/or active comparator-controlled trials (BE READY, BE VIVID and BE SURE), which evaluated the efficacy and safety of bimekizumab in 1,480 adults with moderate to severe plaque psoriasis. <Read More>

New Indication/Dosage/Formulation Approval

Rozlytrek® (entrectinib) Capsules – New Label Expansion –October 20, 2023 – The Food and Drug Administration granted accelerated approval to entrectinib (Rozlytrek®, Genentech Inc.) for pediatric patients older than 1 month with solid tumors that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory standard therapy. In August 2019, FDA granted accelerated approval to entrectinib for pediatric patients 12 years of age and older for this indication. FDA also approved a new oral pellet formulation for entrectinib, and the prescribing information now includes instructions for making an oral suspension from the capsules. <Read More>

Voxzogo® (vosoritide) Lyophilized Powder for Injection – New Label Expansion –October 20, 2023 – BioMarin Pharmaceutical Inc. (Nasdaq: BMRN), a global biotechnology company dedicated to transforming lives through genetic discovery,  announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for Voxzogo® (vosoritide) to increase linear growth in pediatric patients with achondroplasia with open epiphyses (growth plates). This indication is approved under accelerated approval based on an improvement in annualized growth velocity. Previously, Voxzogo® was indicated for children who were 5 years of age and older. This expanded indication now includes children of all ages with open growth plates. <Read More>

New Drug Shortage

October 24, 2023

October 23, 2023

October 18, 2023

October 17, 2023

Updated Drug Shortage

October 24, 2023

October 20, 2023

October 19, 2023

October 18, 2023

New Drug Recall and Safety Alerts

No new update.

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Experiential Education Paves the Way for the Future of Pharmacy Curricula – October 23, 2023 – Innovative experiential learning can provide students with skills necessary to launch successful careers, keeping the pharmacy profession trusted by patients. The pharmacy profession is constantly evolving die to legislative changes, FDA guidance and requirements, corporate pressures, and the demands of patients. The training of pharmacists must also change to match the demand, law, or policy. Experiential education, although not new in the required pharmacy school curriculum, can be the source of innovation that enables students to feel confident to take on the ever-changing world of pharmacy after graduation. There are many ways innovative experiential learning is changing pharmacy education; however, 3 stand out as timely and impactful. <Read More>

The Rise of the Chief Pharmacy Officer – October 20, 2023 – Pharmacy leaders have already cracked the code of hospital C-suites, but increasingly, they’re entering executive positions across health systems. Most hospitals employ a pharmacy director, and some health systems have promoted employees to become chief pharmacy officers — a term created in 2000 to equate pharmacy executives to chief nursing, medical and information officers, according to a 2022 article from the American Society of Health-System Pharmacists. “What distinguishes the pharmacy executive from the established director of pharmacy position is the increased breadth and depth of the involvement in the health system’s strategic planning and decision-making processes at the most senior levels,” the ASHP said. <Read More>

Express Scripts Conspired to Overcharge Pharmacies, Class Action Says – October 20, 2023 – A group of pharmacies has filed a proposed class action lawsuit accusing Cigna Group’s (CI.N) pharmacy benefit manager unit Express Scripts Inc of conspiring with another company to charge higher fees and reimburse pharmacies at lower rates. In a complaint filed Thursday in federal court in Milwaukee, Wisconsin, four retail pharmacies said that a three-year collaboration agreement announced in 2019 between Express Scripts and Prime Therapeutics was in fact a pretext for fixing reimbursement rates and fees, with no benefit for customers. <Read More>

Pharmacy Group Urges US to Block Optum-Amedisys Deal – October 19, 2023 – Independent pharmacies and lawmakers are asking the federal government to probe UnitedHealth Group’s proposed scoop of Amedisys, one of the largest home health and hospice care providers in the U.S. In June, UnitedHealth Group’s Optum division announced plans to acquire Amedisys for $3.3 billion, and a few months later, an overwhelming majority of its shareholders approved the potential transaction. Amedisys has more than 500 care centers across 37 states. Legislators and local pharmacies are skeptical, though, arguing that the deal could weaken competition and hurt patients. <Read More>

AMCP Panel: Biosimilars to See Another Bump by 2025 – October 18, 2023 – The year 2023 was big for biosimilars, which saw eight such products added to the market for adalimumab (Humira, AbbVie). The space is continuing to grow, panelists said during the AMCP Nexus 2023 meeting, with 2025 expected to be another strong year for the addition of new biosimilars. The rate of biosimilar uptake has been generally increasing over time, said Chelsee Jensen, PharmD, BCPS, PRCM, a senior pharmacy specialist and pharmaceutical formulary manager for Mayo Clinic, in Rochester, Minn. The average market share for therapeutic areas with biosimilars launched within the last three years is 75%, she noted, citing data from Amgen Biosimilars’ 2022 Biosimilars Trend Report. <Read More>

Healthcare Bills Suspended in the House – October 18, 2023 – With the removal of Rep. Kevin McCarthy (R-Calif.) as speaker of the House, the legislative arm of Congress was suspended for more than 14 days, which delayed several legislative objectives supported by pharmacists, explained Jennifer Mathieu, the senior vice president of Professional and Government Affairs at the Academy of Managed Care Pharmacy. “As of right now, there is no speaker of the House, so there is no way for any of the legislation to move forward,” Ms. Mathieu explained at the AMCP Nexus 2023 meeting on Oct. 17. “The unprecedented move to vacate Kevin McCarthy from the House essentially puts a hold on all healthcare bills.” <Read More>

Amazon Pharmacy’s Drone Delivery Service Lifts Off With Initial Service in College Station, Texas – October 18, 2023 – Amazon Pharmacy is launching drone delivery for prescription medication orders with the service initially taking flight in College Station, Texas, the company announced Wednesday. The pharmacy deliveries will be dropped, quite literally, outside a consumer’s front door within 60 minutes at no additional cost for eligible Amazon Pharmacy customers, the company said. Amazon Pharmacy is teaming up with the online retailer’s drone service, Prime Air, which kicked off commercial deliveries in the same Texas city in December. <Read More>

340B in the News

Penn Hospital Gets $86M in 340B Settlement – October 23, 2023 – The Hospital of the University of Pennsylvania, one of the largest participants in the 340B drug pricing program, is poised to be granted $86 million by the government as part of a legal settlement, The Philadelphia Inquirer reported Oct. 23. Penn Medicine, based in Philadelphia, ranks among the leading beneficiaries nationwide of the 340B federal initiative, which is designed to offer substantial discounts on prescription drugs used in outpatient clinics or for at-home use to eligible nonprofit hospitals. The settlement, according to the publication, effectively addresses past reductions in the program. <Read More>

The 340B Program Is Increasing Medicare Part B Costs – October 20, 2023 – Last week, the Centers for Medicare & Medicaid Services (CMS) released the rates Medicare beneficiaries will pay in 2024 for Parts A (hospital care) and B (physician services, outpatient care, and certain home health services and durable medical equipment), including the standard premium and deductible. Medicare beneficiaries will see a cost increase for both their standard premium and deductible – and CMS points to the 340B Drug Pricing Program (340B Program) as one factor increasing costs. Let’s walk through the details. <Read More>