Soleno Therapeutics Receives FDA Approval for VYKAT XR Treatment

Soleno Therapeutics has received FDA approval for VYKAT XR (diazoxide choline) extended-release tablets, the first treatment specifically for hyperphagia in individuals aged 4 and older with Prader-Willi syndrome (PWS). This approval is a significant milestone for both the company and the PWS community, addressing a critical unmet need in the treatment landscape. VYKAT XR is expected to be available in the U.S. starting in April 2025 and is backed by a comprehensive clinical development program demonstrating its efficacy and safety. The company has also launched a patient support program to facilitate access to the medication. Experts in the field have expressed excitement over the approval, highlighting its potential to improve the quality of life for individuals with PWS. However, Soleno will need to manage associated risks and ensure effective market penetration to maximize this opportunity.