FDA Green-Lights First Treatment For Prader-Willi Syndrome

Federal regulators are cleaning a first type treatment for the symptoms of a rare neurodevelopmental disorder that is characterized by an insatiable hunger.

Food and medication administration approved a medication this week known as Vykat XR to treat hyperfagia, or a sense of incessant hunger, in children and adults with Prader-Willi syndrome.

The constant desire to eat is a distinctive seal of Prader-Willi, a genetic condition that affects about 350,000 people worldwide, according to the Prader-Willi Syndrome Association, United States, which can lead to obesity and other health problems. People with condition often experience symptoms that begin in childhood, which can include a weak muscle tone, difficulty happening, swallowing and other physical problems, as well as learning difficulties, development delays and behavioral problems.

«The approval of the VYKAT XR FDA is an incredible achievement for the entire PWS community,» said Dr. Jennifer Miller, a professor of pediatric endocrinology at the University of Florida who specializes in treating children and adults with the syndrome and who is a principal researcher in the Vykat XR development program. «I am excited to have Vykat XR available to help treat hyperfagia, which is the most limiting aspect of the life of PWS. Families of people with PWS have been prisoners in their own homes due to the need to provide constant supervision 24/7 with access to completely restricted food.»

The new medicine, developed by Soleno Therapeutics, was approved based on four years of double and open label studies, said the company.

Vykat XR is expected to be available for people with Prader-Willi as young as 4 years since April.