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US FDA Expands Label For BMS’s Camzyos Days After Phase III Stumble

 
• By Alaric DeArment

The agency loosened requirements for echocardiograms and removed contraindications for a number of commonly used drugs.

Bristol Myers Squibb office building in Brisbane, CA
• Source: Shutterstock

Bristol Myers Squibb anticipates expanding the pool of patients eligible for Camzyos (mavacamten) in the treatment of obstructive hypertrophic cardiomyopathy (oHCM) with the US Food and Drug Administration’s loosening of monitoring requirements and contraindications. That should help to partially compensate for a recent clinical setback for the drug in non-obstructive HCM (nHCM).

Key Takeaways
  • The FDA gave BMS’s Camzyos a label expansion to reduce the burden of echocardiogram monitoring for patients from every 12 weeks to every six months.

On 17 April, the FDA updated Camzyos’s prescribing information to reduce the requirement for echocardiogram monitoring from every three months to every six months and remove...

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