Bristol Myers Squibb launches Kopozgo in India for treatment of symptomatic Obstructive Hypertrophic Cardiomyopathy

New Delhi: Bristol Myers Squibb (BMS) has announced the launch of Kopozgo® (Mavacamten) in India.

Kopozgo is the first and only oral, selective cardiac myosin inhibitor approved in India for the treatment of adults with symptomatic New York Heart Association (NYHA) Class II–III obstructive hypertrophic cardiomyopathy (oHCM).

Symptomatic obstructive HCM is an often-inherited heart disease that can be a chronic, debilitating and progressive condition where patients may experience symptoms of shortness of breath, dizziness and fatigue as well as serious, life-altering complications, including heart failure, arrhythmias, stroke and in rare cases (~1%) sudden cardiac death. It affects about 1 in 500 people worldwide, and it is estimated that as many as 2.8 million people in India may be living with the condition; however, 80-90 % patients remain undiagnosed.

Existing medical treatments in India, such as beta blockers, calcium channel blockers, and disopyramide, reduce symptoms but do not address the underlying cause. Invasive surgical procedures, including septal reduction therapy (alcohol septal ablation or myectomy), are options but may not be suitable or available for all patients. Additionally, these procedures require substantial operator and surgical expertise. Therefore, medical management of oHCM remains a major unmet need.

Kopozgo is the firstin-class disease-specific treatment targeting the core pathophysiological mechanism of obstructive HCM, leading to improvement in functional capacity of heart and symptoms.

Mavacamten was approved by the Central Drugs Standard Control Organisation (CDSCO) with an import license issued on March 6, 2025. Kopozgo is now available to patients in India. The approval of Kopozgo in India is based on positive efficacy and safety results from two Phase III clinical trials, EXPLORER-HCM and VALOR-HCM.

Sanjay Sharma, General Manager and Managing Director, BMS India, mentioned, “With the launch of Kopozgo in India, patients with oHCM now have a promising first-in-class treatment option. This breakthrough brings hope to individuals and families facing this condition, giving clinicians a novel therapy to address the unmet need in treatment. Bristol Myers Squibb is committed to advancing cardiovascular care for patients in India.”

Globally, mavacamten has been widely recognized, with its first approval granted by the U.S. Food and Drug Administration (FDA) on April 28, 2022, followed by approval from the European Union on June 26, 2023. Since then, the medicine has continued to expand its reach, receiving marketing authorization in more than 50 countries, underscoring its global significance as a breakthrough therapy for symptomatic obstructive hypertrophic cardiomyopathy.

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.