Pfizer/Lilly Discontinue Tanezumab, The Likely End For A Class Dogged By Safety
The nerve growth factor inhibitor for osteoarthritis pain is one of the last still in development after safety largely sidetracked the class of drugs.
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Panelists say REMS would need data on long-term safety and progression of joint damage after discontinuation. In 19-1 vote, advisory committee concludes proposed Risk Evaluation and Mitigation Strategy will not ensure the anti-nerve growth factor’s modest benefits outweigh risks of joint destruction in osteoarthritis patients.
Given serious safety questions with tanezumab, the US filing seemed like throwing a Hail Mary; two FDA advisory panels overwhelmingly rejected the proposed risk management plan.
Regeneron's antibody cocktail for SARS-Cov-2 is largely in holding mode for now, but the company announced progress on other fronts including for Dupixent in COPD and the NGF inhibitor fasinumab.