Soleno Therapeutics has announced that its drug for a critical symptom of the rare genetic disorder Prader-Willi Syndrome (PWS) has been granted approval by the U.S. Food and Drug Administration (FDA).
The drug, diazoxide choline, will go to market under the name Vykat XR. It will treat hyperphagia, a symptom associated with a feeling of insatiable and abnormally strong hunger, in PWS patients. Hyperphagia is one of many symptoms of PWS which is caused by a loss of genetic material in chromosome 15.
Principal Investigator in the drug’s clinical development program, PWS specialist, and Professor of Pediatric Endocrinology at the University of Florida, Gainesville, Jennifer Miller, called the approval: “an incredible achievement for the entire PWS community.”
She said that hyperphagia was “the most life-limiting aspect of PWS. Families of people with PWS have been prisoners in their own homes because of the need to provide constant, eyes-on supervision 24/7 with access to food being completely restricted.”
Vykat XR will be available for in adults and children 4 years of age and older in the form of extended release tablets. Soleno expects the drug to be available in the U.S. beginning in April 2025.
