Advisory committee will weigh in on desmopressin as FDA questions broad indication and says clinical meaningfulness of treatment effects for Serenity Pharmaceuticals/Allergan’s product vs. placebo are unclear.
FDA has raised several questions about Serenity Pharmaceuticals LLC/Allergan PLC’s desmopressin nasal spray for treatment of nocturia, including about the study design, the clinical meaningfulness of efficacy data, and the proposed broad patient population, which suggest the sponsor may have a difficult time before FDA’s advisory panel.
FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee is to consider the new drug application for Serenity’s SER120 (desmopressin nasal...
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.
