Daprodustat gets a thumbs up from a US FDA advisory committee on one of two proposed indications, but panelists indicate preference for strong pharmacovigilance program for GSK’s oral anemia treatment for chronic kidney disease patients.
GSK plc’s oral anemia drug for chronic kidney disease failed to nab US Food and Drug Administration advisors’ endorsement for one of its two proposed indications at a 26 October advisory committee due to safety concerns.
Advisors also signaled they would also want tight control of the drug’s use in its other indication to optimize safety.
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.
