Monday, December 29, 2025

BMS launches selective cardiac myosin inhibitor drug in India

Bristol Myers Squibb (BMS) has expanded its therapeutic offerings in India into cardiology with the launch of selective cardiac myosin inhibitor Kopozgo (Mavacamten).

The development builds on the company’s strong presence in oncology and haematology, BMS said in a release on launch of the drug for treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).

Mavacamten was approved by the Central Drugs Standard Control Organisation (CDSCO) with an import license issued on March 6, 2025. The approval in India is based on positive efficacy and safety results from two phase III clinical trials, the company said in a release on Monday.

Kopozgo is a first in-class disease-specific treatment targeting core pathophysiological mechanism of obstructive HCM, leading to improvement in functional capacity of heart and symptoms. Globally, the U.S. Food and Drug Administration first approved the drug in April, 2022, followed by European Union approval in June, 2023. Ever since, the drug has received marketing authorisation in more than 50 countries, BMS said.

In two phase III clinical studies, Mavacamten has shown a consistent efficacy and safety profile. Some of the patients experienced a transient drop in ejection fraction (the heart’s pumping ability); however, all patients recovered following interruption, the company said.

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