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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Measures aimed at mitigating risk of progressive joint damage with the first-in-class nerve growth factor inhibitor may not be clinically feasible to implement or prevent rapid progression of osteoarthritis, FDA reviewers say; agency briefing document describes efficacy as 'modest' and says the sponsor's patient preference study was flawed and 'uninformative.'
Pfizer and Lilly plan to resume Phase III testing of their nerve growth factor inhibitor after FDA lifted a partial hold on tanezumab. But J&J is also poised to run new Phase III studies with fulranumab.
Pfizer is facing further disappointment with its promising first-in-class nerve growth factor (NGF) inhibitor, tanezumab. It has been forced by the US FDA to suspend clinical trials of the agent in chronic low back pain and painful diabetic peripheral neuropathy, following the recent suspension of the lead osteoarthritis programme due to safety concerns.