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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Chief scientific officer David Altshuler talked to Scrip about the late-stage development plan for a drug that could represent a blockbuster-sized commercial opportunity, after two Phase II studies testing VX-548 met their primary endpoints.
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.