FDA briefing document cites safety concerns over osteoarthritis drug tanezumab

The primary safety concern associated with this investigational nerve growth factor inhibitor is rapidly progressing osteoarthritis (RPOA). FDA said that the proposed Risk Evaluation and Mitigation strategy is not sufficient to ensure benefits of tanezumab outweigh risks of RPOA.

SPS commentary:

Pfizer and Eli Lilly had submitted a Biologics License Application to the FDA for tanezumab 2.5mg SC, for treatment of patients with chronic pain due to moderate-to-severe osteoarthritis who have experienced inadequate pain relief with other analgesics. A licencing application has also been submitted in the EU.

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