Camzyos is already approved in the US, to treat adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM, and the FDA granted the expanded label indication based on data from the Phase 3 VALOR-HCM study
US FDA expands Camzyos label indication. (Credit: Steve Buissinne from Pixabay)
Bristol Myers Squibb (BMS) has received the expanded US Food and Drug Administration (FDA) approval for Camzyos (mavacamten) to reduce patients’ need for septal reduction therapy (SRT).
Camzyos is an allosteric and reversible cardiac myosin inhibitor that reduces the dynamic left ventricular outflow tract (LVOT) obstruction and improves cardiac filling pressures.
It is already approved in the US, to treat adults with New York Heart Association (NYHA) class II-III obstructive HCM, based on results from the Phase 3 EXPLORER-HCM trial.
The US FDA approved the company’s supplemental New Drug Application (sNDA) for the label expansion, based on positive data from the Phase 3 VALOR-HCM study.
Camzyos label also contains a boxed warning about risk of Heart Failure, as the drug reduces left ventricular ejection fraction (LVEF) and can cause heart failure.
Considering the associated heart failure risk, the drug is offered only through a restricted program under ‘Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program’.
Bristol Myers Squibb US commercial senior vice president and general manager Catherine Owen said: “At Bristol Myers Squibb, we are committed to delivering innovative medicines to help improve the lives of patients living with serious diseases.
“CAMZYOS is the first and only FDA-approved cardiac myosin inhibitor that specifically targets the underlying source of the disease and is redefining the treatment landscape for symptomatic NYHA class II–III obstructive HCM.
“Results from the Phase 3 VALOR-HCM study reinforce the data from the Phase 3 EXPLORER-HCM trial and further strengthen the clinical profile of CAMZYOS. We are proud to offer this important therapy to patients.”
The VALOR-HCM was a randomized, double-blind, placebo-controlled, multicentre Phase 3 study of Camzyos, compared to placebo.
In the Phased 3 study, patients with symptomatic, obstructive HCM (NYHA class II-IV) who were referred for SRT, were randomised to receive either Camzyos or placebo for 16 weeks.
The treatment using Camzyos significantly reduced need for SRT at Week 16, or to proceed with SRT prior to or at Week 16, which is the composite endpoint.
In the study, no new adverse reactions were identified, and 82% of patients no longer eligible for the surgical procedure have decided not to proceed with SRT after 16 weeks.
VALOR-HCM trial investigator and executive committee member Anjali T Owens said: “SRT is an invasive surgical or catheter-based procedure and is typically available at comprehensive HCM treatment centers.
“In order to provide broader access to treatment for those patients whose obstructive HCM becomes so advanced that guidelines recommend SRT, more treatment options are needed.
“The VALOR-HCM study supports CAMZYOS as an oral treatment for obstructive HCM patients who are recommended for SRT.”