Sanofi's proposed type 1 diabetes treatment may be beneficial for some patients who want more glycemic control and are willing to perform the necessary monitoring, but how would the US FDA define that population in the label?
Sanofi's proposed type 1 diabetes treatment sotagliflozin may provide an important test of the power of personalized medicine and patient-physician decision-making.
Sanofi and development partner Lexicon Pharmaceuticals Inc. have proposed sotagliflozin, an SGLT 1 and SLGT 2 inhibitor, as an...
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.
