Soleno Therapeutics announced that the U.S. Food and Drug Administration has accepted for filing its New Drug Application for DCCR for the treatment of Prader-Willi syndrome in individuals four years and older who have hyperphagia. The FDA granted Priority Review for the NDA and assigned a Prescription Drug User Fee Act target action date of December 27, 2024. Priority review is designated to applications for drugs that, if approved, would provide a significant improvement in safety or effectiveness of the treatment, prevention or diagnosis of a serious condition. In its Priority Review Designation letter, the FDA also stated that it is currently planning to hold an advisory committee meeting to discuss the application for DCCR.
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