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REMS For Mavacamten Could Involve Additional Monitoring, BMS Says

User Fee Delayed; Potential For Systolic Dysfunction Needs Watching

 
• By Mandy Jackson

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.

The 90-day extension of the US Food and Drug Administration review deadline, announced 19 November, shifts the action date for mavacamten from 28 January to 28 April to allow sufficient...

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