US advisory committee unanimously impressed by the 90% plus efficacy; FDA says label may note lack of data in those who've previously had shingles.
The US FDA's Vaccines and Related Biological Products Advisory Committee enthusiastically recommended approval of GlaxoSmithKline PLC 's shingles vaccine Shingrix, saying they were impressed by the efficacy data and that an "imbalance" in certain adverse events could be addressed in ongoing monitoring and evaluation.
During the panel's Sept. 13 meeting, several members praised GSK and FDA for the thorough analysis of the clinical data....
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.
