HT Bureau
GUWAHATI, Oct 27: Bristol Myers Squibb (BMS) has announced the launch of Kopozgo® (Mavacamten) in India for the treatment of adults with symptomatic New York Heart Association (NYHA) Class II–III obstructive hypertrophic cardiomyopathy (oHCM).
Kopozgo is the first and only oral, selective cardiac myosin inhibitor approved in India that directly targets the underlying pathophysiology of obstructive HCM.
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Obstructive HCM is often inherited and can be a chronic and progressive condition.
Patients typically experience shortness of breath, dizziness and fatigue, and may face serious complications, including heart failure, arrhythmias, stroke and, in rare cases, sudden cardiac death.
The condition affects approximately 1 in 500 people worldwide, and an estimated 2.8 million individuals in India may be living with it, although 80–90 per cent remain undiagnosed.
Current treatment options in India, such as beta blockers, calcium channel blockers and disopyramide, are aimed at symptom control rather than addressing the root cause.
Surgical procedures including septal reduction therapy are available but may not be suitable for all patients and require specialised expertise, leaving a significant unmet medical need.
Kopozgo is the first disease-specific therapy that works by targeting the core mechanism of obstructive HCM and improving the functional capacity of the heart.
Mavacamten received approval from the Central Drugs Standard Control Organisation (CDSCO), with an import licence issued on March 6, 2025, and is now available for patients in India.
Its approval is based on positive efficacy and safety results from Phase III clinical trials EXPLORER-HCM and VALOR-HCM.
Sanjay Sharma, General Manager and Managing Director of BMS India, said the launch offers a “promising first-in-class treatment option” for patients with obstructive HCM and represents a significant step in addressing unmet clinical needs in the country.
Globally, mavacamten was first approved by the US FDA on April 28, 2022, followed by approval in the European Union on June 26, 2023, and has since received authorisation in more than 50 countries.
In clinical studies, the treatment demonstrated consistent efficacy and safety, although some patients experienced a temporary reduction in ejection fraction, which resolved after treatment interruption.
Bristol Myers Squibb has been operating in India for over two decades, primarily providing treatments in oncology and hematology.
The introduction of Kopozgo marks the company’s expansion into cardiology in the country.
