Pfizer Inc. and Eli Lilly and Company have held out hope for approval of their first-in-class nerve growth inhibitor tanezumab in a substantial commercial market despite a serious risk profile that put the clinical trial program on hold and later led it to be scaled back. If tanezumab could win US Food and Drug Administration approval in osteoarthritis pain, where the risk appeared greatest, the companies believed label expansions could follow.
Pfizer/Lilly Had Big Ambitions For Tanezumab; Are They Finally Dashed?
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.
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