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FDA delays Bristol-Myers Squibb's first-in-class cardiomyopathy drug listing application

 Last Update: 2021-12-06
 Source: Internet
 Author: User

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Author: Shi Bei

On November 19, Bristol-Myers Squibb (BMS) announced that the FDA will extend mavacamten's New Drug Application (NDA) review period for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) by 3 months.

The FDA notified BMS on November 18, 2021 that it will extend the PDUFA date to allow sufficient time to review information related to the proposed risk assessment mitigation strategy (REMS) update, which is part of the initial application for Mavacanten

Hypertrophic cardiomyopathy (HCM) is a chronic progressive disease in which excessive contraction of the myocardium and reduced left ventricular filling capacity can lead to the development of cardiac dysfunction

The Phase III clinical results, code-named EXPLORER-HCM, showed that compared with the placebo group, Mavacamten showed clinically significant improvements in symptoms, functional status and quality of life in patients with symptomatic oHCM, reaching all primary and secondary clinical endpoints

Mavacamten was originally developed by MyoKardia.

In China, on the day of its establishment (August 2020), Liantuo Biotech announced that it had reached a strategic cooperation with MyoKardia to introduce the development and commercialization rights of mavacamten in China and other Asian regions.

Liantuo plans to conduct a Phase III registration study code-named EXPLORER-CN and a pharmacokinetic (PK) study

"We are confident

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