Soleno Therapeutics Submits New Drug Application to FDA for PWS Treatment

On June 28, 2024, Soleno Therapeutics announced the company officially submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for DCCR (diazoxide choline) extended-release tablets. This new treatment targets Prader-Willi syndrome (PWS) in individuals aged 4 and older with hyperphagia.
CEO Anish Bhatnagar, M.D., says, “Submission of the DCCR NDA to the FDA marks a significant milestone not only for Soleno, but for people living with PWS. This regulatory submission advances us one important step closer to our goal of bringing to market a new therapeutic for individuals with PWS that addresses the life-threatening hyperphagia and other key aspects of this serious and rare condition. We look forward to working with the FDA throughout the review process. We extend sincere gratitude to the team at Soleno, investigators, study site teams, advocacy organizations and most importantly, the individuals with PWS and their families who were instrumental in completing our DCCR development program.”
With Breakthrough, Fast Track, and Orphan Drug Designations, Soleno hopes for a Priority Review to expedite the FDA’s process. Learn more and read the full press release at the button below.

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