Entasis’s sulbactam-durlobactam gets solid review from FDA ahead of its 17 April advisory committee meeting, but the company looks like it will have to settle for a narrower indication than it initially proposed.
Innoviva, Inc. subsidiary Entasis Therapeutics Holdings Inc. appears to be headed for an easy US Food and Drug Administration advisory panel for its combination antibacterial sulbactam-durlobactam (SUL-DUR) on 17 April, but it won’t be for the more lucrative pathogen-specific indication the company wanted.
The Antimicrobial Drugs Advisory Committee will vote on whether the overall benefit-risk assessment is favorable for use of SUL-DUR in...
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.
