Unclear data on monoclonal antibody's efficacy caused many members of Pulmonary-Allergy Drugs Advisory Committee to vote against recommending approval.
GlaxoSmithKline PLC's Nucala (mepolizumab) did not receive a positive advisory committee recommendation in COPD largely because of efficacy data clouded by a lack of a well-defined patient population.
The US FDA's Pulmonary-Allergy Drugs Advisory Committee voted 16-3 July 25 that the benefit-risk profile did not support an approval...
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.
