Soleno Therapeutics Says FDA Determines No Need For Advisory Committee Meeting For DCCR NDA

(RTTNews) - Providing a regulatory update from the U.S. Food and Drug Administration (FDA) on Tuesday, biopharmaceutical company Soleno Therapeutics, Inc. (SLNO) said the FDA Review Division has determined that there does not appear to be a need for an advisory committee meeting at this time for the New Drug Application (NDA) for DCCR (diazoxide choline) extended-release tablets for the treatment of Prader-Willi syndrome (PWS).

However, the FDA added that the Division's review team will continue to consider the potential need for an advisory committee meeting during their ongoing review.

As announced previously, the DCCR NDA was designated for Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of December 27, 2024.