REMS For Mavacamten Could Involve Additional Monitoring, BMS Says

User Fee Delayed; Potential For Systolic Dysfunction Needs Watching

The FDA will take three more months to review mavacamten, a treatment for hypertrophic cardiomyopathy that BMS expects to be one of the company’s next blockbusters.

Stethoscope And Stress Ball In Heart Shape On Wooden Background — The action date for mavacamten has moved from 28 January to 28 April • Source: Alamy

A delay in the user fee deadline for Bristol Myers Squibb Company’s cardiac drug mavacamten over a proposed risk evaluation and mitigation strategy (REMS) could involve the need for additional monitoring, the company told Scrip. It remains to be seen if the REMS requirements could diminish mavacamten’s profile versus a competitor with a similar mechanism of action.

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Zai’s R&D Head Touts ‘Beauty’ Of Novel Internal Assets

01 May 2025

• By Dexter Jie Yan

Two potentially first-in-class molecules signify Zai Lab’s renewed drive for the in-house discovery of drugs that it requires “to be innovative, differentiated and to have the potential to make a big difference for patients,” its global R&D head tells Scrip.