CDSCO Panel Grants Bristol-Myers Squibb's Protocol Amendment proposal for Mavacamten
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major Bristol-Myers Squibb's protocol amendment for the clinical study titled, 'A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy".
This came after Bristol-Myers Squibb presented protocol amendment 02 dated 02 August 2023 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).
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 9th January 2023, the expert panel reviewed the proposal presented by the drug major Bristol-Myers Squibb for the protocol amendment for the clinical study of Mavacamten.
After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.
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