USFDA updates Camzyos label to reduce echocardiography monitoring requirements, contraindications: Bristol Myers Squibb
Princeton: Bristol Myers Squibb has announced that the U.S. Food and Drug Administration (FDA) has updated the U.S. Prescribing Information for CAMZYOS (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules), simplifying treatment for patients and physicians by reducing the required echo monitoring for eligible patients in the maintenance phase and expanding patient eligibility by reducing contraindications.
CAMZYOS is a FDA-approved cardiac myosin inhibitor for the treatment of adults with symptomatic New York Heart Association (NYHA) Class II-III obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms.
“In addition to the established efficacy of CAMZYOS, these meaningful updates to the label reinforce the strong safety profile of the therapy. With robust clinical and real-world data and more than 15,000 patients prescribed CAMZYOS in the U.S., this medicine has redefined the treatment landscape for symptomatic obstructive HCM and can have a significant impact for patients living with the condition,” said Al Reba, senior vice president, Cardiovascular & Immunology Commercialization at Bristol Myers Squibb. “Simplifying treatment by reducing the frequency of echo monitoring not only improves the patient experience, but will also save time for cardiologists, allowing them to treat more patients.”
FDA-approved updates include reduced frequency of required echo monitoring from once every 12 weeks to every 6 months for patients with left ventricular ejection fraction (LVEF) ≥55% and a Valsalva left ventricular outflow tract (LVOT) gradient <30 mmHg (or Valsalva LVOT ≥30 mmHg without up-titration) who have reached the maintenance phase (at Week 12 or later).
Additionally, CAMZYOS is no longer contraindicated with moderate CYP2C19 inhibitors and strong CYP3A4 inhibitors, which were adjusted to drug interactions. This provides physicians with greater flexibility in prescribing CAMZYOS to a broader group of eligible patients, with revised dosing and monitoring.
The approved label update is supported by long-term clinical and real-world data, including analyses of results from the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program, real-world experience from three single-center studies, and ongoing clinical data reinforcing the safety profile of CAMZYOS through 3.5 years.
CAMZYOS is included in both the ESC and AHA/ACC/Multisociety clinical guidelines as a recommended option for patients with persistent symptoms on a first-line therapy and is established as a standard of care for the treatment of adults with symptomatic obstructive HCM, supported by a growing body of evidence.
The full U.S. Prescribing Information for CAMZYOS includes a Boxed WARNING for the risk of heart failure. CAMZYOS reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction. Echocardiogram assessments of LVEF are required prior to and during treatment with CAMZYOS. Initiation of CAMZYOS in patients with LVEF <55% is not recommended. Interrupt CAMZYOS if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status. Concomitant use of CAMZYOS with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of CAMZYOS is contraindicated with strong CYP2C19 inhibitors and moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers. Because of the risk of heart failure due to systolic dysfunction, CAMZYOS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CAMZYOS REMS PROGRAM.
