Approval of Waiver on Government Site Condition for Bristol Myers Cardiac Drug Mavacamten Trial: CDSCO Panel

New Delhi: Reviewing the proposal presented by Bristol-Myers, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has accepted the waiver of the condition stating that 50% of trial sites should be government sites and 50% of subjects shall be enrolled from government sites of the clinical trial to study Mavacamten in non-obstructive hypertrophic cardiomyopathy.

This came after the firm presented for waiver of condition (i) 50% of trial sites should be government sites and 50% of subjects shall be enrolled from government sites, Protocol No: CV027031.

The purpose of this study is to evaluate the safety, tolerability, and efficacy of mavacamten compared with placebo in participants with symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM).

This is a randomized, double-blind, placebo-controlled clinical study to evaluate mavacamten in adults with symptomatic non-obstructive hypertrophic cardiomyopathy.

Mavacamten is a myosin inhibitor used to treat obstructive hypertrophic cardiomyopathy.

Mavacamten is a small-molecule allosteric and cardiac myosin inhibitor. It was developed by MyoKardia, a subsidiary of Bristol Myers Squibb. In clinical studies, mavacamten has demonstrated significant efficacy in reducing cardiac muscle contractility by targeting the sarcomere hypercontractility that is one of the characteristics of hypertrophic cardiomyopathy and inhibits excessive myosin actin cross-bridge formation, shifting the overall myosin population towards an energy-sparing, recruitable, super-relaxed state.

Mavacamten is indicated for the treatment of adults with symptomatic New York Heart Association class II-III obstructive hypertrophic cardiomyopathy to improve functional capacity and symptoms.

At the recent SEC meeting for cardiovascular held on July 18, 2024, the expert panel reviewed the proposal presented by the drug major Bristol-Myers to waive the condition stating that 50% of trial sites should be government sites and 50% of subjects shall be enrolled from government sites.

After detailed deliberation, the committee accepted the waiver of condition (i) 50% of trial sites should be government sites and 50% of subjects shall be enrolled from government sites as presented by the firm.

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