Camzyos Secures FDA Approval for Obstructive HCM, Bristol Myers Eyes it as its Next Big Cardiac Drug

Bristol Myers Squibb (BMS) was granted US Food and Drug Administration (FDA) approval for its highly awaited cardiac drug Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM).

The FDA approved 2.5 mg, 5 mg, 10 mg and 15 mg capsules of Camzyos for adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.

The drug is touted to be a future blockbuster for BMS, which has been looking to refuel its cardiac pipeline as its top-selling drug Eliquis is due to go off patent in 2026 after having received an extension from its original date in 2023.

BMS had targeted Camzyos in its acquisition of MyoKardia in 2020 for $13.1 billion.

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“This approval builds on decades of cardiovascular leadership and reflects our steadfast commitment to people impacted by cardiovascular disease. We are proud to bring this first-of-its-kind medicine to patients, which may help to address an unmet need in the US in the symptomatic NYHA class II-III obstructive HCM treatment landscape,” said Samit Hirawat, MD, chief medical officer at Bristol Myers, in a news release from BMS.

HCM involves thickening of the fibers of the heart muscle, causing the walls of the heart muscle to enlarge and thicken. Camzyos is the first FDA-approved drug that targets the pathophysiology of HCM as it inhibits cardiac myosin to alleviate symptoms and induce functional improvement.

It is a selective allosteric and reversible cardiac myosin inhibitor that blocks the interaction between myosin and actin, another key muscle protein.

Symptoms of HCM include shortness of breath (especially with physical exertion), chest pain, palpitations, weakness and fatigue. As a result, HCM patients often have difficulties performing daily physical activities like climbing stairs, lifting weights or playing sports.

Conventional HCM treatment has involved treating symptoms with drugs such as beta-blockers or calcium channel blockers. Camzyos, however, selectively inhibits cardiac myosin to trigger functional and symptomatic improvements, Dr. Hirawat said in an interview with Fierce Pharma.

By blocking myosin, Camzyos reduces dynamic left ventricular outflow tract (LVOT) obstruction and enhances cardiac filling pressures in HCM patients.

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Camzyos’ approval was based on data from BMS’ double-blind, randomized, placebo-controlled, parallel-group Phase III EXPLORER-HCM clinical trial, which enrolled 251 adults with symptomatic, obstructive HCM.

Data from the trial revealed that 37 percent of participants who received Camzyos met the composite primary endpoint (defined by improvements in venous oxygen tension and in NYHA class by a minimum of one, among others) versus 17 percent in the placebo group.

Last year, BMS launched a HCM awareness campaign, which includes a ‘Could It Be HCM’ website that provides educational materials on symptoms and other resources for patients. As part of the campaign, BMS teamed up with NBA rookie Jared Butler who was diagnosed with the condition at age 18 during a routine health exam. He did not have any symptoms at the time of his diagnosis.

Camzyos comes with a boxed warning label for the risk of heart failure. Given this, BMS said the medication will only be available under a Risk Evaluation and Mitigation Strategy (REMS) program. FDA review of BMS’ REMS program led to a delay in Camzyos’ approval deadline, which was originally in January.

Overall, the drug has been well-tolerated, Hirawat said. “We want to make sure that the benefits always outweigh the risk and therefore the REMS program is being implemented in parallel,” he explained.

As some of BMS’ best-selling drugs including multiple myeloma drug Revlimid and blood thinner Eliquis reach the patent cliff, the company shared in January that it is banking on four key prospects (this cardiac drug mavacamten, anemia drug Reblozyl, autoimmune med deucravacitinib and immuno-oncology candidate relatlimab) to help it reach peak sales of more than $4 billion alone or in combinations.