Takeda’s Uloric: CV Mortality Signal Leads US FDA To Ponder Regulatory Options
Advisory committee will discuss whether CARES postmarketing trial showing 34% increased risk of cardiovascular death for febuxostat warrants market withdrawal, use restrictions, or new labeling for the gout drug.
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Takeda’s Uloric Gets CV Death Warning And Restricted Indication, But No REMS
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.
Uloric U-Turn: Gout Therapy Likely To Stay On Market Despite CV Safety Concern
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.
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.