FDA delays decision on Bristol Myers Squibb’s new heart disease drug
The FDA has extended its review of mavacamten, Bristol Myers Squibb’s new drug for treating patients with symptomatic hypertrophic cardiomyopathy (oHCM).
A decision is now expected to be delivered by April 28, 2022. The FDA said this extension was needed so that the agency could review the proposed risk evaluation mitigation strategy. No new data or studies were requested.
Findings from the EXPLORER-HCM phase II clinical trial, shared with the public back in May 2020, suggested mavacamten could provide significant value for patients with oHCM. MyoKardia, the drug’s manufacturer at the time, was acquired by Bristol Myers Squibb in October 2020 for a whopping $13.1 billion.
“We are confident in the profile of mavacamten,” Samit Hirawat, MD, executive vice president and chief medical officer of global drug development for Bristol Myers Squibb, said in a statement. “This first-in-class cardiac myosin inhibitor demonstrated clinically meaningful improvements in symptoms, functional status, and quality of life in symptomatic oHCM patients in the pivotal EXPLORER-HCM trial. We look forward to continuing to work closely with the FDA to bring this important medicine to patients.”
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.