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Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint

 
• By Sue Sutter

As US FDA weighs fate of Takeda’s febuxostat, advisory committee members suggest REMS to ensure prescribers have informed benefit/risk conversation with patients, but agency staff highlight design and assessment challenges for such a program.

3D illustration of a matrix with tablets and the words risks and benefits. Concept of clinical trials results - Illustration

There was a striking dissonance at the recent US FDA advisory committee review of Takeda Pharmaceuticals USA Inc.’s Uloric (febuxostat) between panelists and agency staff over the role that a Risk Evaluation and Mitigation Strategy (REMS) could or should play in the gout drug’s continued marketing.

On one side were several panelists who believed a REMS should be used for educational purposes to help reinforce with doctors information about febuxostat’s cardiovascular (CV) safety in light of...

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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