FDA approval for first drug to treat inherited heart condition

pharmafile | April 29, 2022 | News story | Medical Communications  

Bristol Myers Squibb has received approval from the FDA for their drug, Camzyos™ (mavacamten), marking the drug as the first to treat the cause of an inherited form of heart failure known as obstructive hypertrophic cardiomyopathy.

Camzyos has been approved for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive hypertrophic cardiomyopathy (obstructive HCM).

The approval makes Camzyos the first and only FDA-approved allosteric and reversible inhibitor selective for cardiac myosin that targets the underlying pathophysiology of obstructive HCM. The drug has been approved to improve functional capacity and systems.

“This is a first-in-class medicine specifically for patients living with symptomatic obstructive HCM,” said Milind Desai, MD, MBA, director of the Hypertrophic Cardiomyopathy Center and director of clinical operations in Cleveland Clinic’s Heart Vascular & Thoracic Institute. “With this FDA approval, US cardiologists now have a new pharmacological option for eligible patients that targets the underlying pathophysiology of the disease.”

The approval is based on data from the Phase III EXPLORER-HCM trial.

“The approval of Camzyos represents a significant milestone for appropriate symptomatic obstructive HCM patients and their families, who have long awaited a new treatment option for this chronic and progressive disease,” said Anjali T Owens, MD, Medical Director of the Center for Inherited Cardiac Disease and an Assistant Professor of Medicine at the Perelman School of Medicine at the University of Pennsylvania. “As a lead U.S. investigator on the EXPLORER-HCM study, I’m grateful to the patients and their families whose participation in the trial played a key role in this approval.”

HCM treatment has traditionally centered around mitigating symptoms, using drugs such as beta blockers or calcium channel blockers. By contrast, Camzyos selectively inhibits myosin, to trigger functional and symptomatic improvements.

Ana Ovey

Related Content

No items found

Latest content