Bristol-Myers Squibb (BMY) said late Thursday that the US Food and Drug Administration has updated prescribing information for the company's cardiac myosin inhibitor Camzyos to reduce echocardiography monitoring requirements and contraindications.
The regulator streamlined treatment for patients and physicians by lowering the required echo monitoring for eligible participants in the maintenance phase to every six months from once every 12 weeks, and expanding patient eligibility by reducing contraindications, the company added.
The FDA's decision was based on clinical and real-world data, including results from the Camzyos risk evaluation and mitigation strategy program, Bristol-Myers said.
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