Pfizer and Eli Lilly’s long journey to a potential FDA approval for tanezumab still looked rocky today after review documents from the regulator cast doubt over its safety.
Ahead of an outside expert committee meeting midweek, the FDA as always released its thoughts and discussion points on the drug, and, while finding strong evidence that it helps osteoarthritis patients, it says there are critical safety risks that may cost the partners a straight shot on goal.
The main safety worry is so-called rapidly progressing osteoarthritis, or RPOA, which the companies are aware of. They are looking to run the drug under the FDA’s Risk Evaluation and Mitigation Strategy (REMS) to try to keep a close eye on this issue.
