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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Dunn’s participation at the panel meeting ended speculation that he left the US FDA.
Study showed osteoarthritis patients are more willing to accept risk of joint damage with NGF-inhibitors than dependency associated with opioids, Pfizer said; however, FDA highlighted key flaws in study design, sample population and survey content.
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.