Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and...

Soleno Therapeutics Announces U.S. FDA Acceptance for Filing and Priority Review of NDA for DCCR (Diazoxide Choline) Extended-Release Tablets in Prader-Willi Syndrome



Priority review with PDUFA December 27 but with an advisory committee meeting first to discuss DCCR application:

PDUFA target action date set for December 27, 2024
FDA currently plans to hold an Advisory Committee meeting​

REDWOOD CITY, Calif., Aug. 27, 2024 (GLOBE NEWSWIRE) -- Soleno Therapeutics, Inc. (“Soleno” (NASDAQ: SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing its New Drug Application (NDA) for DCCR for the treatment of Prader-Willi syndrome (PWS) 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 (PDUFA) 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.
“PWS is a devastating, rare condition that significantly impacts the lives of patients and their families,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno. “The FDA’s acceptance of our NDA is a significant milestone, and designating our application for priority review reaffirms that the FDA views PWS as a serious condition. We are immensely grateful to the entire PWS community, including patients, caregivers and advocacy groups, for their ongoing support. We remain committed to continuing to work closely with the FDA through the NDA review process.”
Diazoxide choline has Breakthrough and Fast Track Designations in the U.S., as well as Orphan Drug Designation for PWS in the U.S. and E.U


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