FDA accepts Bristol Myers' pitch for former MyoKardia drug; Clovis' Rubraca aces advanced ovarian cancer study
The program at the centerpiece of Bristol Myers Squibb’s buyout of MyoKardia just got one step closer to gaining potential FDA approval.
BMS announced Friday that the agency has accepted its NDA pitch, scheduling a Jan. 28, 2022 PDUFA date for the experimental drug mavacamten. The company is shooting for an initial indication of symptomatic obstructive hypertrophic cardiomyopathy, or oHCM.
In the disease, a mutation in proteins forces the heart to exert more effort and squeeze more, blocking the outflow of blood and thickening muscle. Mavacamten is an oral allosteric modulator of cardiac myosin, intended to reduce contraction by the heart muscle.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.