Here is information on the latest US FDA approvals, the week of February 19 – February 23, 2024
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Enmetazobactam for cUTI, Dupilumab for COPD, Melphalan Flufenamide Withdrawal, Teclistamab Biweekly Dosing, Linvoseltamab in RRMM
Enmetazobactam for cUTI
The FDA approved enmetazobactam (Exblifep) for the treatment of complicated urinary tract infections (cUTIs), including pyelonephritis, in patients aged 18 years or older. This agent, in combination with the fourth-generation cephalosporin cefepime, is designed to combat antimicrobial resistance in gram-negative bacteria. This approval is based on the results of a randomized, controlled, double-blind, global phase 3 trial comparing enmetazobactam to the standard treatment piperacillin-tazobactam in terms of clinical cure and microbiological eradication. cUTIs, requiring therapy, affect approximately 3.6 million patients in the US annually, presenting symptoms such as chills, fever, back pain, and malaise. Enmetazobactam is expected to be available in the US market in the upcoming quarters. The approval of enmetazobactam was granted to Orchid Pharma.https://www.contemporaryobgyn.net/view/fda-grants-new-drug-approval-to-enmetazobactam-against-cutis
Dupilumab for COPD
The FDA has granted priority review for dupilumab (Dupixent) as an add-on maintenance treatment for certain adult patients with uncontrolled chronic obstructive pulmonary disease (COPD). This application is based on positive results from 2 phase 3 trials, suggesting that dupilumab could become the only biologic therapy for COPD and the first new treatment approach for this disease in over a decade. Dupilumab is a human monoclonal antibody that inhibits interleukin-4 (IL-4) and interleukin-13 (IL-13) signaling, mechanisms involved in the inflammatory process of several conditions, including COPD. The priority review for dupilumab was granted based on findings from the BOREAS and NOTUS phase 3 trials, which demonstrated that dupilumab significantly reduced the annualized rate of moderate or severe acute COPD exacerbations. The approval of dupilumab for this indication is under review, with a target action date for the FDA decision set for June 27, 2024. Approval of dupilumab for COPD if granted, will be to Regeneron Pharmaceuticals, Inc., and Sanofi, expanding its use beyond its current 5 FDA-approved indications.
https://www.globenewswire.com/news-release/2024/02/23/2834219/0/en/Press-Release-Dupixent-sBLA-accepted-for-FDA-Priority-Review-for-treatment-of-COPD-with-type-2-inflammation.html
https://www.regeneron.com/downloads/dupixent_fpi.pdf
Melphalan Flufenamide Withrawal
The FDA has withdrawn approval for melphalan flufenamide (Pepaxto), previously approved in combination with dexamethasone for treating certain patients with multiple myeloma. This decision, effective immediately, comes after a confirmatory study failed to confirm the clinical benefit of melphalan flufenamide and evidence showed the drug was not proven to be safe or effective under its conditions of use. This marks the first application of amended procedures for the withdrawal of accelerated approval, introduced by the Food and Drug Omnibus Report Act of 2022 (FDORA) in 2023. The FDA’s final decision was announced by Peter Marks, MD, PhD, Director of the Center for Biologics Evaluation and Research, and concludes the process initiated under these new regulations. Oncopeptides, the manufacturer, had been given an explanation for the proposed withdrawal and an opportunity to appeal, which they utilized without changing the outcome. Melphalan flufenamide will also be removed from the Orange Book. Further details on this decision are available in the FDA’s public docket.
https://www.fda.gov/drugs/drug-safety-and-availability/fda-issues-final-decision-withdraw-approval-pepaxto-melphalan-flufenamide
Teclistamab Biweekly Dosing
The FDA has approved the supplemental Biologics License Application for teclistamab-cqyv (Tecvayli), now permitting its use once every 2 weeks to treat patients with relapsed or refractory multiple myeloma. This update in dosing frequency specifically targets patients who have achieved and maintained at least a complete response (CR) for a minimum of 6 months, aiming to offer more flexibility in their treatment schedule. This update follows the initial approval of teclistamab under the FDA’s accelerated pathway in October 2022 as a novel treatment. Teclistamab is a bispecific T-cell engager antibody that targets the BCMA protein and CD3 receptor. The biweekly dosing approval is based on data from the phase I/II MajesTEC-1 study, which demonstrated that patients transitioning to a biweekly dosing schedule after achieving CR for 6 months or longer could maintain deep responses to teclistamab. This regimen was shown to be safe, with fewer grade 3 or higher infections reported and no new safety concerns after switching to the biweekly schedule. This approval was granted to Johnson & Johnson.
Linvoseltamab in RRMM
The biologics license application (BLA) of linvoseltamab, another bispecific T cell engager being evaluated in RRMM, has been accepted for priority review. Specifically it is for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma (MM) that has progressed after receiving at least three prior therapies. The target action date for the FDA’s decision is set for August 22, 2024. Linvoseltamab is an investigational bispecific antibody designed to connect B-cell maturation antigen on MM cells with CD3-expressing T cells, thereby enhancing T-cell activation and facilitating the destruction of cancer cells. This application is supported by data from the ongoing LINKER-MM1 trial, a phase 1 and phase 2 study, which enrolled 282 patients with R/R MM. The study evaluated linvoseltamab through a step-up dosing regimen followed by a full dose. The manufacturer of linvoseltamab is Regeneron.
https://investor.regeneron.com/news-releases/news-release-details/linvoseltamab-bla-treatment-relapsedrefractory-multiple-myeloma
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