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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Lilly plans a head-to-head study of donanemab versus Biogen’s Aduhelm to see which clears amyloid plaque better and has begun a rolling BLA toward accelerated approval of the Alzheimer’s drug.
The nerve growth factor inhibitor for osteoarthritis pain is one of the last still in development after safety largely sidetracked the class of drugs.
The company said the study of JTA-004 failed to meet its primary and key secondary endpoints, though a post-hoc analysis indicated activity in a patient subset.