With Wegovy’s new indication for cardiovascular risk reduction in patients with overweight and obesity, the migration of diabetes drugs from a single disease state to address a host of interrelated conditions reaches a new milestone.
The migration of diabetes drugs from a single disease state to address a host of interrelated conditions reached a new milestone with the FDA’s approval of Novo Nordisk A/S’s Wegovy (semaglutide) as the first weight loss drug with an indication for reducing risk of major cardiovascular events in patients with overweight or obesity.
Wegovy is a higher-dose version of Novo’s glucagon-like peptide-1 receptor agonist Ozempic, which was first approved in 2017 to improve...
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.
Stay up to date on regulatory guidelines from around the world with the Pink Sheet's Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
