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Bristol’s Mavacamten Shows Consistent Efficacy, Safe Use In Obstructive HCM At ACC

US FDA Decision On First Indication Due On 28 April

 
• By Mandy Jackson

Long-term results from the EXPLORER-HCM extension study are consistent with the pivotal trial in obstructive hypertrophic cardiomyopathy, while data from VALOR may support a supplemental filing.

Heart shaped pills on a black background
Oral pill mavacamten is pending US FDA approval at the end of April • Source: Alamy

Bristol Myers Squibb Company has high expectations for its first-in-class cardiac myosin inhibitor mavacamten in hypertrophic cardiomyopathy (HCM), with peak annual sales predicted at more than $4bn. The company presented data at the American College of Cardiology (ACC) Scientific Sessions on 2 and 3 April in obstructive HCM (oHCM) that may help BMS make the case for strong commercial use of the drug based on safety and efficacy in a long-term study and in patients with more advanced disease.

Bristol’s multibillion-dollar sales estimate for mavacamten is based on multiple indications. The US Food and Drug Administration is reviewing the first, with a decision expected by 28 April, based on...

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