- FDA updates CAMZYOS monitoring requirements, reducing frequency from 12 weeks to 6 months for eligible patients.
- Contraindications for moderate CYP2C19 and strong CYP3A4 inhibitors have been removed.
- Supported by data from over 15,000 patients, CAMZYOS continues to carry a Boxed Warning for heart failure risk.
Bristol Myers Squibb (BMY, Financial) has announced that the U.S. Food and Drug Administration (FDA) has updated the prescribing information for CAMZYOS® (mavacamten), a medication used for the treatment of symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM). The updates to the medication's label promise to ease treatment requirements and expand patient eligibility.
One core change is the reduction of the required echocardiography monitoring frequency from every 12 weeks to every 6 months for patients who have reached the maintenance phase with stable left ventricular ejection fraction (LVEF) of 55% or higher and specific LVOT gradient criteria. This adjustment aims at lessening the burden on patients and healthcare providers alike, allowing cardiologists to manage more patients without compromising care quality.
Additionally, the label changes remove contraindications for moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors, widening the eligibility for CAMZYOS prescription. This modification provides physicians with greater flexibility in managing treatment plans and expands the potential patient base by allowing more individuals with comorbidities to benefit from CAMZYOS.
Supported by robust data drawn from more than 15,000 U.S. patients, CAMZYOS has demonstrated a strong safety profile over 3.5 years, reflected by clinical studies and real-world experience. Despite these advancements, CAMZYOS remains subject to a Boxed Warning due to associated heart failure risks and is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program, ensuring continued safety and efficacy monitoring.
