Pfizer’s Tanezumab REMS Cannot Make Benefit-Risk Positive, US FDA Panel Says
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.
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A number of new medicines are moving closer to the EU market after the European Medicines Agency recommended in favor of their approval.
Sponsors of several new medicines are set to learn if their products are on track for pan-EU approval. One product on the list is Pfizer/Lilly’s osteoarthritis drug, tanezumab, which recently ran into trouble in the US.
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.