365telugu.com online news,India, October 14th, 2025: Bristol Myers Squibb (BMS) has unveiled Kopozgo® (Mavacamten) in India, marking the introduction of the nation’s first and only oral, selective cardiac myosin inhibitor for adults with symptomatic New York Heart Association (NYHA) Class II–III obstructive hypertrophic cardiomyopathy (oHCM).
Symptomatic obstructive HCM is a frequently inherited cardiac condition that can become chronic, debilitating, and progressive. Patients often face symptoms like shortness of breath, dizziness, and fatigue, along with severe complications such as heart failure, arrhythmias, stroke, and, in rare instances (about 1%), sudden cardiac death. Globally, it impacts roughly 1 in 500 individuals, with estimates suggesting up to 2.8 million people in India could be affected—yet 80-90% of cases go undiagnosed.[i]
Current treatments in India, including beta blockers, calcium channel blockers, and disopyramide, primarily alleviate symptoms without tackling the root cause.[ii] Invasive options like septal reduction therapy (e.g., alcohol septal ablation or myectomy) exist but demand high levels of expertise and aren’t accessible or appropriate for everyone. As a result, effective medical management of oHCM continues to represent a significant gap in care.
As a first-in-class therapy, Kopozgo specifically targets the underlying pathophysiology of obstructive HCM,[iii] enhancing heart function and easing symptoms to improve patients’ quality of life.
The Central Drugs Standard Control Organisation (CDSCO) granted approval for Mavacamten on March 6, 2025, via an import license. Kopozgo is now accessible to eligible patients across India, supported by robust efficacy and safety data from the Phase III EXPLORER-HCM and VALOR-HCM trials.
Sanjay Sharma, General Manager and Managing Director of BMS India, commented, “The arrival of Kopozgo offers a groundbreaking, first-of-its-kind option for oHCM patients in India.
This innovation instills hope for those affected and equips clinicians with a targeted tool to meet longstanding treatment needs. At Bristol Myers Squibb, we’re dedicated to elevating cardiovascular care and delivering impactful solutions to Indian patients.”
On the global stage, Mavacamten has earned widespread acclaim, starting with U.S. FDA approval on April 28, 2022, and European Union authorization on June 26, 2023. It now holds marketing approval in over 50 countries, affirming its role as a pivotal advancement in managing symptomatic obstructive HCM.
Across the two Phase III trials, Mavacamten demonstrated reliable efficacy and a favorable safety profile. While some participants noted a temporary decline in ejection fraction (a measure of the heart’s pumping efficiency), all recovered fully after brief treatment pauses.
With more than two decades in India, Bristol Myers Squibb has established itself as a leader in oncology and hematology therapies. The rollout of Kopozgo signifies a strategic expansion into cardiology, broadening the company’s portfolio. BMS remains focused on accelerating access to world-class global treatments for more patients in India.