Panel for first-ever marijuana derivative will discuss safety issues, including link to transaminase elevations, but low potential for abuse and strong efficacy suggest a smooth route to approval.
It seems as if the US FDA's calling of an advisory committee to vote on the risk/benefit profile of GW Pharmaceuticals PLC's childhood epilepsy drug Epidiolex (cannabidiol) is largely designed to cover the agency's bases, in that there is no agency-approved drug containing the marijuana derivative.
But the Peripheral and Central Nervous System Drugs Advisory Committee will also be weighing in on a number of safety...
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.
