Camzyos is said to be the first and only FDA-approved cardiac myosin inhibitor that specifically targets the source of obstructive HCM, and the FDA approval is based on the Phase 3 EXPLORER-HCM trial
FDA approves Camzyos to treat obstructive HCM. (Credit: Pexels from Pixabay)
Bristol Myers Squibb (BMS) has received the US Food and Drug Administration (FDA) approval for Camzyos (mavacamten) 2.5mg, 5mg, 10mg, 15mg capsules to treat adults with a type of obstructive hypertrophic cardiomyopathy (HCM).
The drug was indicated for adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.
Camzyos is the first and only cardiac myosin inhibitor approved by the US FDA that targets the underlying pathophysiology of obstructive HCM.
The drug works by modulating the number of myosin heads that can enter “on actin” (power-generating) states, to reduce the probability of systolic and diastolic cross-bridge formation.
Camzyos comes with a Boxed WARNING for the risk of heart failure, as it reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.
Also, it requires echocardiogram assessments of LVEF before and during the treatment, where patients with LVEF of less than 55% are not recommended for the treatment.
It is advised to interrupt the Camzyos treatment if the patient’s LVEF levels are below 50% or experiences heart failure symptoms or worsening clinical status, said the company.
Bristol Myers Squibb global drug development executive vice president and chief medical officer Samit Hirawat said: “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 U.S. in the symptomatic NYHA class II-III obstructive HCM treatment landscape.”
The FDA approval is supported by positive data from the Phase 3 EXPLORER-HCM trial, which enrolled 251 adults with symptomatic obstructive HCM.
The primary endpoint of the study was a composite functional endpoint, defined as the proportion of patients achieving improvement of mixed venous oxygen tension (pVO2), accompanied by improvement in NYHA class.
In the study, a large proportion of study participants in the Camzyos arm met the primary endpoint at week 30, compared to those in the placebo group.
Also, patients receiving Camzyos showed superior improvement across all secondary endpoints, compared to the placebo group at Week 30, said the company.