US advisory committee strongly endorses cardiovascular risk reduction claim for the GLP-1 agonist but some panelists say new indication should be limited to diabetics with established CV disease, not the broad primary prevention claim Novo Nordisk is seeking.
Novo Nordisk AS’s Victoza (liraglutide) appears on track to add cardiovascular benefit labeling following a US FDA advisory committee’s endorsement June 20 but the supplemental indication could end up narrower than the sponsor would like.
The Endocrinologic and Metabolic Drugs Advisory Committee voted 17-2 that the results from the LEADER CV outcomes trial provided substantial...
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.
