The FDA will release its verdict on June 16 regarding Bristol Myers Squibb‘s sNDA proposing to use its heart drug Camzyos (mavacamten) to lower the need for septal reduction therapy (SRT) in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM).
Currently, many patients suffering from HCM need to undergo SRT, Roland Chen, senior vice president and head of cardiovascular development, Global Drug Development at BMS, said in a statement upon the FDA’s acceptance of the sNDA. SRT is either an open-heart surgical procedure or a catheter-based operation.
BMS supported Camzyos’ sNDA with data from the Phase III VALOR-HCM study, a randomized, double-blinded and placebo-controlled trial that enrolled 112 patients with symptomatic obstructive HCM. All participants were qualified for SRT and had been referred for the operation.
VALOR-HCM’s primary endpoint was a composite between the number of patients who decided to push through with SRT by week 16 and the number of patients who remain eligible for SRT as determined by their left ventricular outflow tract (LVOT) gradient and New York Heart Association classification.
Key secondary endpoints included exercise gradient LVOT and serum biomarkers after 16 weeks of treatment. Camzyos cleared all primary and secondary endpoints “with a high degree of statistical significance,” according to BMS’s announcement.

Reference: https://www.biospace.com /