FDA Accepts Bristol Myers’ Application to Expand Heart Drug Indication

The FDA has accepted Bristol Myers Squibb’s supplemental New Drug Application (sNDA) of Camzyos (mavacamten) to reduce the need for septal reduction therapy for patients with symptomatic obstructive hypertrophic cardiomyopathy, a chronic, progressive disease in which the heart muscle becomes thick.

Camzyos helps regulate the heart’s contraction, as excessive contraction of the heart makes it more difficult for blood to circulate throughout the body.

The drug was approved in April for treatment of adult patients with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.

The FDA has set a decision date of June 16, 2023 for the sNDA.