Is There A REMS In Uloric’s Future? US FDA Panelists Say Yes, Agency Says Not Likely
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.
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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.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Drug safety focused meetings would once have been almost certain to focus on mandatory risk management plans as a solution. But FDA not only didn’t propose that approach, it actively discouraged its advisors from considering it.