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.
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.
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