Pfizer has run 41 trials over 15 years for tanezumab. As adcomm nears, the FDA remains unimpressed — and more than a little worried
Ahead of an advisory committee meeting later this week, the FDA on Monday released its in-depth review of Pfizer and Eli Lilly’s anti-NGF osteoarthritis drug tanezumab, concluding that it “provides substantial evidence of effectiveness” but also raising concerns that the proposed risk evaluation and mitigation strategy (REMS) may not be enough to lessen its significant safety risks.
The safety questions at hand deal with reports of unusual and unexpected joint-related adverse events in tanezumab-treated patients with osteoarthritis, FDA explained, noting, “The review team has concerns that the Applicant’s proposed REMS is not sufficient to mitigate the risk of RPOA [Rapidly Progressing Osteoarthritis] and would not ensure that the benefits of tanezumab outweigh the risks of RPOA.”
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