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Clinical Insights: April 17, 2024

Posted on April 17, 2024 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

Zevtera® (ceftobiprole medocaril) for Injection – New Drug Approval – April 3, 2024 – The U.S. Food and Drug Administration approved Zevtera® (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 years old with community-acquired bacterial pneumonia (CABP). Zevtera®’s efficacy in treating SAB was evaluated in a randomized, controlled, double-blind, multinational, multicenter trial. In the trial, researchers randomly assigned 390 subjects to receive Zevtera® (192 subjects) or daptomycin plus optional aztreonam [the comparator] (198 subjects). <Read More>

Risvan® (risperidone) for Injection – New Drug Approval – April 2, 2024 – Laboratorios Farmacéuticos Rovi, S.A. (“ROVI” or the “Company”) has announced that the U.S. Food and Drug Administration (FDA) has authorised the marketing of Risvan® (Risperidone ISM®) for the treatment of schizophrenia in adults. Risperidone ISM® is a prolonged-release injectable antipsychotic developed and patented by ROVI for the treatment of schizophrenia in adults, which, as of the first injection, provides immediate and sustained plasmatic drug levels and does not require loading doses or supplementation with oral risperidone. <Read More>

New Indication/Dosage/Formulation Approval

Enhertu® (fam-trastuzumab deruxtecan-nxki) Injection – New Label Expansion – April 5, 2024 – AstraZeneca and Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. <Read More>

Carvykti™ (ciltacabtagene autoleucel) Suspension for Intravenous Infusion – New Label Expansion – April 5, 2024 – The FDA approved ciltacabtagene autoleucel (brand name Carvykti™) for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Ciltacabtagene autoleucel is a B-cell maturation antigen-directed genetically modified autologous chimeric antigen receptor T-cell therapy. Each dose is customized using a patient’s own T-cells, which are collected and genetically modified, and infused back into the patient. <Read More>

Dovato® (dolutegravir and lamivudine) Tablets – New Label Expansion – April 5, 2024 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, announced the U.S. Food and Drug Administration (FDA) approved Dovato® (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of Dovato®. <Read More>

Fasenra® (benralizumab) Injection – New Label Expansion – April 5, 2024 – AstraZeneca’s Fasenra® (benralizumab) is now approved by the US Food and Drug Administration (FDA) for add-on maintenance treatment for patients with severe asthma aged 6 to 11 with an eosinophilic phenotype. Fasenra® was first approved in 2017 as an add-on maintenance for the treatment of severe eosinophilic asthma (SEA) in patients aged 12 and older. This additional indication for Fasenra® was supported by evidence from TATE, an open-label, multinational, non-randomized, parallel assignment Phase III trial, as well as adequate and well-controlled trials in adult and adolescent populations. In the TATE study, Fasenra® met the primary endpoints, demonstrating pharmacokinetics (PK) and pharmacodynamics (PD) in children aged 6 to 11 years old with SEA were consistent with those seen in prior trials. <Read More>

Xcopri® (cenobamate) Tablets – New Label Expansion – April 5, 2024 – SK Life Science, Inc., a U.S. pharmaceutical company developing treatments that will change the future of central nervous system (CNS) disorders and a subsidiary of SK Biopharmaceuticals, Co., Ltd. announced the U.S. Food and Drug Administration (FDA) approved two new administration options of Xcopri® (cenobamate tablets) CV, an antiseizure medication (ASM) for adults with partial-onset (focal) seizures, which can now be crushed and mixed with water and either administered by mouth as an oral suspension or administered via a nasogastric tube. <Read More>

Abecma® (idecabtagene vicleucel) Suspension for Intravenous Infusion – New Label Expansion – April 4, 2024 – Bristol Myers Squibb (NYSE: BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) have announced that the U.S. Food and Drug Administration (FDA) approved Abecma® (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial. This approval expands Abecma®’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. Abecma® is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. <Read More>

Fanapt® (iloperidone) Tablets – New Label Expansion – April 2, 2024 – Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) announced that the U.S. Food and Drug Administration (FDA) has approved Fanapt® (iloperidone) tablets for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults. Fanapt® is an atypical antipsychotic agent that has been used for the acute treatment of patients with schizophrenia since its FDA approval in 2009. <Read More>

New Drug Shortage

April 15, 2024

April 12, 2024 

April 03, 2024

Updated Drug Shortage

April 12, 2024

April 10, 2024

April 08, 2024

April 04, 2024

April 03, 2024

New Drug Recall and Safety Alerts

Relyvrio® (sodium phenylbutyrate/taurursodiol) – New Drug Discontinuation

April 4, 2024 – Amylyx Pharmaceuticals, Inc. (NASDAQ: AMLX) (“Amylyx” or the “Company”) announced the Company has started a process with the U.S. Food and Drug Administration (FDA) and Health Canada to voluntarily discontinue the marketing authorizations for Relyvrio®/Albrioza™ (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]; also known as AMX0035) and remove the product from the market in the U.S. and Canada based on topline results from the Phase 3 PHOENIX trial. Relyvrio®/Albrioza™ will no longer be available for new patients. Patients currently on therapy in the U.S. and Canada who, in consultation with their physician, wish to stay on treatment can be transitioned to a free drug program. <Read More>

New Generic/Biosimilar Approval and Launch

No new update.

Clinical and Pharmacy News

Insulin Glargine Biosimilar Demonstrates Bioequivalence to Originator for Type 2 Diabetes –April 13, 2024 – Findings from a phase 3, multicenter, open-label, equivalence trial suggest similar immunogenicity, efficacy, and safety between originator insulin glargine (Lantus®) and its proposed biosimilar (Basalin®) in adult patients with type 2 diabetes. Patients treated with the biosimilar experienced similar rates of positivity for treatment-induced glycated hemoglobin by week 26 versus those treated with the originator, including patients with and without previous insulin glargine exposure, and with a comparable frequency and nature of treatment-emergent adverse events. <Read More>

Diabetes Weight Loss Drugs Could be Linked to Reduced Risk of MS, Study Finds – April 12, 2024 – Drug repurposing has recently emerged as an attractive pathway for developing new treatments due to its relatively fast and cost-efficient trajectory. Because obesity and MS share inflammatory properties, researchers used data from the FDA Adverse Event Reporting System to investigate the association between weight loss-inducing drugs and MS. It is known that obesity induces systemic and local inflammation, and studies have shown that obesity in early childhood or adolescence increases the risk of multiple sclerosis (MS), an inflammatory disease of the brain and spinal cord. Furthermore, obesity in newly diagnosed MS patients has been associated with more severe disease, worse outcomes, and diminished response to disease-modifying therapies. <Read More>

St. Jude Takes the Lead on Prevention and Treatment of COVID-19 in Vulnerable Kids – April 11, 2024 – During the COVID-19 pandemic, trying to control the spread of infection became an everyday aspect of life. Masks, hand sanitizer and social distancing were commonplace, with one major goal: to protect the most vulnerable groups from infection. Children with cancer are often left immunocompromised by their treatments, making them among the most at risk of infection from pathogens such as SARS-CoV-2. However, in a recent JAMA Network Open study, St. Jude researchers showed that even when immunocompromised pediatric patients experienced COVID-19, most were asymptomatic or had only mild disease. But having COVID-19 resulted in another problem: Most patients (87%) had their cancer treatments interrupted. <Read More>

The American Diabetes Association is Reevaluating BMI for Weight Management – April 10, 2024 – The American Diabetes Association (ADA) recently published its updated guidelines for 2024—including its new recommendations around body mass index, or BMI, and weight management for type 2 diabetes. Part of the new guidelines, called Standards of Care in Diabetes, include the recommendation that healthcare providers use other measurements of body fat distribution, such as waist circumference, waist-to-hip ratio, and/or waist-to-height ratio in tandem with BMI. In its 2023 guidelines, the ADA focused on BMI. <Read More>

Pharmacy Researchers Examine Trends in Rising Cost of Medicine – April 10, 2024 – Newly published research from the University of Houston College of Pharmacy reveals an alarming trend in diabetic medication expenditures. While pharmaceutical spending in the U.S. has long been recognized as higher than in other affluent nations, diabetic medications, including insulin, are now at the forefront of this surge in prescription drug costs. From 2011 to 2020, total annual prescription medication expenditures rose from $341.49 to $473.12 billion per year with metabolic agents being the costliest category. Among the metabolic agents, antidiabetic agents were the most expensive therapeutic area, with an increasing trend observed from $27.15 to $89.17 billion over the same period. <Read More>

340B in the News

Woodward: Some States Push Back on Blocking Low-Cost Drug Program – April 8, 2024 – Some states are pushing back on attempts by drug companies to roll back a discount program “safety net” health providers use to care for vulnerable, low-income Americans. The 340B Drug Pricing Program lets some hospitals and clinics, mostly in rural, working-class communities, buy outpatient drugs at discounted prices from pharmaceutical manufacturers who participate in Medicaid and Medicare. The program, which does not use tax dollars, enables these “safety net” healthcare organizations to use the savings from these drugs to fund more services for eligible patients and their communities. “The 340B program is vital to our small, rural areas and the healthcare providers who serve them,” said former congressman Billy Long, R-Mo. <Read More>