Osteoarthritis Drug Development: ‘Clinically Meaningful Endpoints’ Remain Elusive
US FDA is ‘willing to look at anything’ but sponsors need to demonstrate an effect on pain as drug development challenges remain. Accompanying chart describes 32 drugs in Phase II and Phase III clinical trials and one with a pending biologics license application.
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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.
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.
Still reeling from the FDA rejection of its JAK inhibitor filgotinib for rheumatoid arthritis, the Belgium-headquartered biotech's ADAMTS-5 inhibitor developed with France's Servier is sunk after failing to significantly reduce cartilage loss compared with placebo in an OA trial.