Therapy Areas: Cardiovascular
Bristol Myers Squibb's CAMZYOS(R) (mavacamten) supplemental new drug application receives US FDA approval
24 October 2022 -

Bristol Myers Squibb (NYSE: BMY), a US-based pharmaceutical company, announced on Friday that the US Food and Drug Administration (FDA) has accepted its supplemental new drug application (sNDA) for CAMZYOS(R) (mavacamten) for an expanded indication to reduce the need for septal reduction therapy (SRT).

CAMYZOS is currently FDA approved for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (HCM) to improve functional capacity and symptoms. Obstructive HCM is a chronic, progressive disease in which excessive contraction of the heart muscle and reduced ability of the left ventricle to fill can make it difficult for blood to circulate to the rest of the body, leading to the development of debilitating symptoms and cardiac dysfunction.

The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of 16 June 2023.

'Currently, it is recommended that many patients with severe symptomatic obstructive hypertrophic cardiomyopathy undergo SRT. This often requires either an open-heart surgical procedure or septal ablation procedure - both specialised care options,' said Roland Chen, MD, senior vice president and head of cardiovascular development, Global Drug Development at Bristol Myers Squibb. 'The approval of CAMZYOS earlier this year marked a significant milestone for patients. FDA acceptance of the filing for this expanded indication has the potential to strengthen the profile of CAMZYOS, while further reinforcing our commitment to delivering transformative cardiovascular therapies to patients.'

The sNDA submission was based on the results of the Phase 3 VALOR-HCM study, a randomized, double-blind, placebo-controlled study, which evaluated CAMZYOS in patients with symptomatic, obstructive HCM (NYHA class III-IV) who met the 2011 ACC/AHA guideline criteria for SRT and who have been referred for an invasive procedure. VALOR-HCM met its primary and all secondary endpoints with a high degree of statistical significance, with no new safety signals observed.

VALOR-HCM (NCT04349072) is a randomised, double-blind, placebo-controlled, multicentre Phase 3 study of patients with symptomatic, obstructive HCM (NYHA class III-IV) who meet guideline criteria for septal reduction therapy (SRT) and have been referred for an invasive procedure. The study enrolled 112 patients randomized on a 1:1 basis to receive mavacamten or placebo.

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