A newly published briefing document from the U.S. Food and Drug Administration (FDA) cites critical safety concerns with Pfizer and Eli Lilly’s anti-NGF osteoarthritis drug tanezumab, despite the fact that clinical trials have demonstrated the agent can help patients with osteoarthritis.
The primary safety concern associated with the drug is rapidly progressing osteoarthritis (RPOA), which both Pfizer and Eli Lilly have observed in their research. The companies are currently looking to evaluate and monitor the drug and the associated safety issue under the FDA’s Risk Evaluation and Mitigation strategy (REMS).
