FDA Approves Vykat XR for PWS

Soleno expects Vykat XR to be available in the U.S. beginning in April 2025.

“The FDA approval of Vykat XR is an incredible achievement for the entire PWS community,” said Jennifer Miller, M.D., Professor of Pediatric Endocrinology at the University of Florida, Gainesville, who specializes in treating children and adults with PWS and is a principal investigator in the Vykat  XR clinical development program. “I am excited to have Vykat  XR available to help treat hyperphagia, which is 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.”

"This approval is a testament to the power of persistence, science, and advocacy," said Susan Hedstrom, Executive Director of the Foundation for Prader-Willi Research. "For years, families and researchers have worked towards a treatment option that truly addresses the complexities of PWS. Today, we take a major step forward in changing the future for individuals navigating hyperphagia associated with PWS."

The FDA approval of Vykat  XR was based on an adequate and well-controlled study and safety data from the comprehensive clinical development program. Efficacy was established during the 16-week randomized withdrawal study period of Study 2-RWP (Study C602-RWP), a Phase III multi-center, randomized, double-blind, placebo-controlled trial. Individuals randomized to switch to placebo demonstrated a statistically significant worsening of hyperphagia compared with individuals who remained on Vykat XR. Prior to participating in the randomized withdrawal period, all individuals received double-blind and/or open-label Vyvkat  XR for a mean duration of 3.3 years.

Vyvat XR  has a well-established safety profile with over four years of data across four double-blind and/or open label studies. The primary safety analyses are based on Study 1 (Study C601) and the most common adverse reactions occurring in greater than or equal to 10% of individuals receiving Vyvat XR XR and at 2% greater than placebo included hypertrichosis, edema, hyperglycemia and rash.

Patient Support for Accessing Vyvat XR;  Soleno has launched Soleno One, a comprehensive patient support program. Information about the program is available at VykatXR.com. The Soleno One team can be reached toll-free at 1-(833)-SOLENO-1 (1-833-765-3661) from 8 a.m. to 8 p.m. ET Monday through Friday. Healthcare providers who want to submit prescriptions can visit VykatXRHCP.com to complete the Start Form that initiates the process for accessing treatment.