Pulmonary-Allergy Drugs Advisory Committee votes 9-7 that the benefits of Pharmaxis' cystic fibrosis drug outweigh its risks, leaving the FDA with a muddled verdict.
The US Food and Drug Administration will have a host of issues to balance as it completes the review of Pharmaxis Ltd.'s cystic fibrosis drug Bronchitol (mannitol inhalation powder) after the Pulmonary-Allergy Drugs Advisory Committee narrowly voted that the risk/benefit profile is adequate to support approval by a 9-7 margin.
At the 8 May meeting, panelists offered a muddled verdict to the agency with a variety of arguments focusing on...
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.
