Cytokinetics willingness to tweak the indication for omecamtiv mecarbil doesn’t look likely to help the drug get past a handful of safety and efficacy concerns at its 13 December advisory panel.
Cytokinetics, Inc. heart failure drug didn’t meet the US Food and Drug Administration’s bar for approval on a single-Phase III trial, agency briefing documents released ahead of a 13 December Cardiovascular and Renal Drugs Advisory Committee meeting indicate.
The underwhelming Phase III study result is just one of many problems FDA reviewers identified in the application for omecamtiv...
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.
