Pfizer’s Tanezumab REMS Faces US FDA Doubts Heading Into Panel Review

 
• By Sue Sutter

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.'

Knee replacement X-ray
Osteoarthritis progression leading to total joint replacement is among the safety issues flagged in FDA's review of tanezumab. • Source: Shutterstock

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