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FDA approves Soleno’s VYKAT XR to treat hyperphagia in Prader-Willi Syndrome

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The FDA has approved Soleno Therapeutics’ VYKAT XR (diazoxide choline) extended-release tablets, previously referred to as DCCR, for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). Soleno expects VYKAT XR to be available in the US beginning in April 2025.


Jennifer Miller (Credit: University of Florida)
Jennifer Miller (Credit: University of Florida)

“The FDA approval of VYKAT XR is an incredible achievement for the entire PWS community,” said Dr Jennifer Miller, Professor of Pediatric Endocrinology at the University of Florida, Gainesville, who specialises in treating children and adults with PWS and is a principal investigator in the VYKAT XR clinical development programme. “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.”


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 randomised withdrawal study period of Study 2-RWP (Study C602-RWP), a Phase 3 multi-centre, randomised, double-blind, placebo-controlled trial. Individuals randomised 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 VYKAT XR for a mean duration of 3.3 years.


“Today marks a historic day for the PWS community. The FDA’s approval of VYKAT XR represents a monumental step forward in addressing the longstanding unmet needs of individuals living with PWS and their families,” said Stacy Ward, Chief Executive Officer of the Prader-Willi Syndrome Association | USA. “Our families experience the constant and disruptive challenges of hyperphagia, and VYKAT XR offers hope to so many.”


VYKAT 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 VYKAT XR and at 2% greater than placebo included hypertrichosis, oedema, hyperglycaemia and rash.


“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.”

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