Soleno Therapeutics (SLNO) said the US Food and Drug Administration approved the company's VYKAT XR tablets to treat hyperphagia in adults and children with Prader-Willi Syndrome, a rare genetic disorder.
The approval was based on efficacy and safety data from a phase 3 trial, the company said Wednesday in a statement.
Soleno expects VYKAT XR to be available in the US in April.