Amidst bipartisan congressional pressure to approve ALS drugs, Billy Dunn, head of FDA’s neuroscience division, told advisory committee members that the law ‘demands’ flexibility in review of Amylyx’s AMX0035, and he came prepared with the citations.
If Amylyx Pharmaceuticals, Inc.’s amyotrophic lateral sclerosis drug AMX0035 secures US Food and Drug Administration approval, it looks to be in no small part thanks to Billy Dunn, director of the Office of Neuroscience in the Office of New Drugs and his interpretation of the agency’s legal duty to exercise the broadest possible regulatory flexibility.
A key part of that regulatory flexibility in this case, per Dunn, is being more comfortable approving a drug that...
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.
