GW Pharmaceuticals’ cannabis-derived epilepsy drug gets unanimous panel endorsement, affirming US FDA's belief that there are no obstacles to approval.
GW Pharmaceuticals PLC's epilepsy drug Epidiolex (cannabidiol) looks destined to be the first cannabis-derived drug approved in the US, as FDA's Peripheral and Central Nervous System Drugs Advisory Committee unanimously backed the risk/benefit profile by a 13-0 margin in a seemingly superfluous meeting April 19.
The agency had come into the meeting with an already positive opinion of Epidiolex, which is specifically designed for the...
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.
