Bronchitol is set to make its second appearance before a US FDA advisory committee, and Chiesi hopes to rely on the drug’s novel mechanism of action and the unmet need in cystic fibrosis to overcome the agency’s concerns about the underlying clinical data.
The US Food and Drug Administration appears to be somewhat sour on the modest efficacy of Pharmaxis Ltd.'s cystic fibrosis treatment Bronchitol (mannitol inhalation powder), and the sponsor may need the Pulmonary-Allergy Drugs Advisory Committee to be sympathetic to the drug's unique mechanism and the disease's unmet need for additional treatments to have a shot at approval.
The committee will convene 8 May to assess the risk/benefit profile of Bronchitol, as Chiesi USA Inc., which is...
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.
