FDA approves updated label for mavacamten
Key takeaways:
- Mavacamten’s label has been updated to include data from VALOR-HCM.
- Mavacamten is linked to less need for septal reduction therapy vs. placebo in patients with obstructive hypertrophic cardiomyopathy.
Bristol Myers Squibb announced that the FDA has approved updated labeling for mavacamten to reflect positive data from the VALOR-HCM trial.
Mavacamten (Camzyos), a cardiac myosin inhibitor, in April 2022 became the first drug approved by the FDA to treat NYHA class II or III obstructive hypertrophic cardiomyopathy (HCM).
As Healio previously reported, in the VALOR-HCM trial, patients with obstructive HCM assigned mavacamten had reduced need for septal reduction therapy (SRT) compared with those assigned placebo.
The label for mavacamten now states that the drug reduced the composite endpoint of guideline-based eligibility for SRT at week 16 or the decision to proceed with SRT before or at week 16, according to a press release from the company.
“SRT is an invasive surgical or catheter-based procedure and is typically available at comprehensive HCM treatment centers. In order to provide broader access to treatment for those patients whose obstructive HCM becomes so advanced that guidelines recommend SRT, more treatment options are needed,” Anjali T. Owens, MD, medical director of the Center for Inherited Cardiac Disease, associate professor of medicine at the Perelman School of Medicine at the University of Pennsylvania and VALOR-HCM trial investigator and executive committee member, said in the release. “The VALOR-HCM study supports Camzyos as an oral treatment for obstructive HCM patients who are recommended for SRT.”
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