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.