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.
Pfizer Inc.’s unsuccessful attempt to use patient preference information (PPI) to sway the US Food and Drug Administration’s view on tanezumab should be a lesson for other sponsors on appropriate study design, particularly when an investigational product has a challenging benefit-risk profile.
Pfizer offered results from a preference study showing patients with moderate to severe osteoarthritis are willing to risk some level...
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
New marketing authorization applications filed with the European Medicines Agency's human medicines committee (the CHMP) for review under the EU's centralized procedure. Updated monthly.
Proposal to have panelists rate the strength of efficacy and safety evidence on a numeric scale also draws support in written comments on ways to optimize the advisory committee process.
A real-world evidence study also does not meet the regulatory standard for an adequate and well-controlled clinical investigation, the agency said. The FDA should allow the accelerated approval drug to remain available like other treatments that failed their confirmatory trials, Intercept said.
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Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
