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Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely

 
• By Sue Sutter

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.

FDA Advisory Committee Feature image

A US FDA advisory committee said Jan. 11 that Takeda Pharmaceuticals USA Inc.’s gout drug Uloric (febuxostat) should stay on the market, but with more restrictive labeling and possibly even a Risk Evaluation and Mitigation Strategy (REMS) – a remedy that the agency suggested would be challenging if not unworkable.

Members of the Arthritis Advisory Committee and Drug Safety and Risk Management Committee overwhelmingly voted that there is a gout patient population for which febuxostat’s benefit/risk profile is favorable, despite an increased

Advisory Committee Vote
  • Based upon the available data, is there a patient population in which the benefit/risk profile for febuxostat is favorable for the treatment of

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