New Indication for Bimzelx
On Nov. 20, 2024, UCB announced that the US Food and Drug Administration (FDA) approved Bimzelx® (bimekizumab-bkzx) to treat adults with moderate-to-severe hidradenitis suppurative (HS), marking its fifth indication. Bimzelx blocks the activity of interleukins (IL) 17A and 17F and was initially approved in 2023 for treating adults with moderate-to-severe plaque psoriasis. With less than a 1% prevalence in the United States, HS is a chronic inflammatory skin disease characterized by swollen, painful abscesses and lumps – primarily under the breasts, between the buttocks, and around the armpits and groin. Usually diagnosed during adolescence and early adulthood, it affects around three times as many American women as men. This approval is based on Phase III trials that showed a higher percentage of patients reaching ≥50% improvement in HS signs and symptoms at week 16 when compared to placebo and clinical improvements, defined as ≥75% reduction in HS signs and symptoms sustained at week 48. To treat HS, the recommended dose of Bimzelx is 320mg by subcutaneous (SC) injection every two weeks for eight doses and then every four weeks thereafter. For full prescribing information, click here.
Labeling Update for Fludarabine Phosphate
The FDA’s Oncology Center of Excellence has a program, Project Renewal, to analyze real-world evidence (RWE) for cancer drugs that were FDA-approved before 2005 when the present format and content standards for prescription drug labels were established. Together with drug manufacturers, independent practicing oncologists and clinicians in related fields critically evaluate publicly available information to document support for drug uses that are not included in the product labeling. Typically, brand drug manufacturers do not seek FDA approval for new indications once their products have lost patent protection. On Nov. 19, 2024, the FDA announced labeling changes to its third drug assessed under this program, fludarabine phosphate (Fludarabine Phosphate Injection, Sandoz®). It was originally approved in 1991 for the treatment of adults with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent-containing regimen. It is now indicated as a component of a combination regimen for the treatment of adults with B-cell CLL and for the treatment of adults with B-cell CLL who have not responded to or whose disease has progressed during treatment with at least one alkylating agent−containing regimen. The dosage regimen was also updated to include the recommended dose in combination with cyclophosphamide and rituximab, and the boxed warning for central nervous system (CNS) toxicity, hemolytic anemia, and pulmonary toxicity was removed and incorporated into warning and precautions. Here is the updated prescribing information.
Generic Byetta Approved
Amneal announced FDA approval of exenatide 5mcg/1.2mL and 10mcg/2.4mL prefilled pen injection on Nov. 21, 2024. This generic references Byetta® (exenatide – AstraZeneca), a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The initial dose of exenatide is 5mcg administered subcutaneously within 60 minutes before the morning and evening meals and then increased to 10mcg twice daily after one month based on glycemic control. Cost and launch information are not known at this time. Prescribing information is here.
Recall
Clonazepam Orally Disintegrating Tablets Recall
On Nov. 19, 2024, Endo Pharmaceuticals, the parent company of Par Pharmaceuticals, notified the FDA of an expansion of its voluntary recall of Clonazepam Orally Disintegrating Tablets due to potential mislabeling of carton strength by a third-party packager. Although the blister strips and tablets inside reflect the correct strength, some outer cartons may be printed with incorrect strength and the National Drug Code (NDC). Clonazepam is a benzodiazepine approved to treat seizures and panic disorder. Inadvertently taking higher doses of clonazepam can cause serious risks like sedation, confusion, and dizziness. There’s also a significant risk of life-threatening respiratory depression, especially in those with lung conditions, near maximum doses or taking other depressants. For more information on this recall, see here.