A US FDA Advisory Committee’s overwhelming rejection of FibroGen/AstraZeneca’s oral anti-anemia agent is a big setback for the sponsor. But the committee’s reaction to novel strategies used to try to save the application has an important message for all drug developers about the limits of those approaches.
By the time the US Food & Drug Administration’s Cardiovascular & Renal Drugs Advisory Committee met to discussion FibroGen, Inc./AstraZeneca PLC’s anti-anemia agent roxadustat on 15 July, it was already clear that the application was in trouble.
FDA had already extended the review deadline – originally set for December 2020 – by three months. Then the agency...
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.
