For the first time/
Vykat XR approved for genetic binge eating disorder
The U.S. Food and Drug Administration (FDA) on Wednesday approved Soleno Therapeutics’ drug to treat a rare genetic disorder, making it the first available treatment for patients who experience intense, persistent hunger.
The drug, called Vykat XR, is approved to treat binge eating disorder (hyperphagia) in people with Prader-Willi syndrome (PWS), a genetic disorder caused by a partial or complete deletion of chromosome 15 that affects the regulation of gene expression, or the switching on and off of genes.
The debilitating condition, which affects about 50,000 people in the United States, affects everyday aspects of life such as eating, behavior and mood.
Victoza XR is scheduled to be available in the United States in April 2025 for patients aged 4 years and older with PWS and binge eating disorder.
The average annual cost of the drug is $466,200, and the dosage will be based on patients’ weight.
