CDSCO Panel Approves Phase IV Protocol Amendment for Bristol-Myers Squibb's Mavacamten Study
New Delhi: The Subject Expert Committee (SEC) under the Cardiovascular division of the Central Drugs Standard Control Organisation (CDSCO) has approved the protocol amendment submitted by Bristol-Myers Squibb India Pvt. Ltd. for the ongoing Phase IV clinical study of Mavacamten capsules (2.5 mg, 5 mg, 10 mg, and 15 mg).
The approval was granted during the SEC Cardiovascular meeting held on 10th July 2025 at CDSCO headquarters, New Delhi.
Bristol-Myers Squibb presented the amendment related to its Phase IV clinical study protocol titled: “A Phase 4, Single-Arm, Open-Label Study to Evaluate Safety, Tolerability, and Efficacy of Mavacamten in Adults with Symptomatic Obstructive Hypertrophic Cardiomyopathy in India (ROVER)” under Protocol No. CV0271146, Amendment 01, dated 5th February 2025.
Following detailed deliberation, the committee recommended approval of the protocol amendment as submitted by the company.
Mavacamten, a cardiac myosin inhibitor, is indicated for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM)—a condition characterized by abnormal thickening of the heart muscle, which can obstruct blood flow and lead to serious cardiac complications. Mavacamten works by reducing excessive cardiac contractility, thereby improving cardiac function and patient outcomes.
The ongoing Phase IV study aims to assess the safety, tolerability, and efficacy of Mavacamten specifically in the Indian adult patient population diagnosed with symptomatic obstructive HCM. The amendment approved by the SEC pertains to modifications within the study protocol, as documented in the submitted version.
Mavacamten, developed by Bristol-Myers Squibb, has been positioned as a first-in-class therapy for obstructive HCM and represents a significant advancement in the management of this cardiac disorder. The approval of the protocol amendment will enable the continued execution of the Phase IV study in India under the updated study design.
