Can A REMS Mitigate CV Risks? Avandia, Meridia Offer Point, Counterpoint
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.
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Despite advisory committee pressure, US FDA stands firm against imposing REMS targeted at gout drug’s cardiovascular risks; however, Takeda must conduct utilization study to see if labeling changes impact prescribing patterns.
US FDA would not have approved Takeda’s Uloric but for a post-market safety study commitment. Now that the study is complete and suggests a potential increased risk of mortality, however, FDA doesn’t seem inclined to pull the product.
Continued availability of Takeda’s febuxostat should be restricted to second-line use in gout patients who cannot tolerate or fail allopurinol, advisory committee majority says, opposing market withdrawal; but panelists’ suggestion that a Risk Evaluation and Mitigation Strategy be put in place to ensure patients and prescribers discuss cardiovascular risks receives pushback from agency.