U.S. Food and Drug Administration Updates CAMZYOS® (mavacamten) Label to Reduce Echocardiography Monitoring Requirements and Contraindications
Bristol-Myers Squibb Company (BMY)
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Source: Business Wire
Label updates include simplified twice-yearly echo monitoring for eligible CAMZYOS patients in the maintenance phase and expanded patient eligibility with reduced contraindicationsUpdated U.S. label is supported by data including long-term clinical and real-world evidence which reinforce the strong safety profile of CAMZYOS PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today 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 the first and only 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 function
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