New FDA Approvals: FDA Approves Soliris Biosimilars for gMG
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Dec 12, 2024
Oct. 23: The FDA granted an additional approval to Amgen Inc.’s Bkemv (eculizumab-aeeb) for the treatment of generalized myasthenia gravis in adults who are anti-acetylcholine receptor (AchR) antibody positive. The agency initially approved the complement 5 inhibitor on May 28, 2024, as biosimilar to and interchangeable with Alexion, AstraZeneca Rare Disease’s Soliris (eculizumab). Dosing for the newest use is 900 mg weekly via intravenous infusion for the first four weeks, then 1,200 mg for the fifth dose one week later and then 1,200 mg every two weeks. The company has settled patent litigation that allows Bkemv to launch March 1, 2025, or an earlier date in certain circumstances. During Amgen’s Oct. 30 call to discuss third-quarter earnings, Murdo Gordon, executive vice president of global commercial operations, revealed that the company was preparing to launch the drug in second-quarter 2025. Drugs.com lists the price of a single-dose 10 mg/mL intravenous solution of Soliris as more than $6,878. Read more
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