US FDA advisory committee will consider impact of trial design, given that GSK did not collect asthma histories and chronic oral corticosteroid use information from its COPD study participants.
The US FDA is questioning the efficacy data and other information supporting the addition of a potentially novel COPD indication to GlaxoSmithKline PLC's Nucala (mepolizumab) in advance of a July 25 advisory committee review of the supplemental application.
Nucala is seeking a claim as an add-on treatment to inhaled corticosteroid-based maintenance treatment for reduction of exacerbations in patients...
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.
