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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

Pfizer Inc.’s proposed Risk Evaluation and Mitigation Strategy for the osteoarthritis drug tanezumab may be neither clinically feasible to implement nor useful in preventing the risk of progressive joint damage from the nerve growth factor inhibitor, the US Food and Drug Administration said.

In advisory committee briefing documents released 22 March, agency reviewers said although the proposed REMS is consistent with mitigation measures implemented during the drug’s clinical development program, “there is no clear evidence to support that requiring and implementing the proposed

Advisory Committee Voting Question
  • Will the REMS proposed by the applicant ensure that the benefits of

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