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FDA OKs First Drug for Hyperphagia in Prader-Willi Syndrome

On March 26, 2025, the FDA approved Soleno Therapeutics' NDA for diazoxide choline extended-release tablets for treating hyperphagia in individuals aged 4 years and older with Prader-Willi syndrome .
PWS is a rare genetic disorder affecting approximately 1 in 15,000 live births and 10,000 to 20,000 people in the U.S., characterized by a hallmark symptom of hyperphagia, a chronic, life-threatening condition causing insatiable hunger.
VYKAT XR is the first FDA-approved therapy to address hyperphagia associated with PWS, representing a significant milestone as previously there were no treatment options available for the most disruptive aspect of this disease.
According to Anish Bhatnagar, MD, CEO of Soleno, the approval is a significant milestone for both the company and the PWS community, while Justice Faith, a 21-year-old with PWS, expressed excitement about the potential treatment option for hyperphagia, with Susan Hedstrom, executive director of the Foundation for Prader-Willi Research, calling the approval a testament to persistence, science and advocacy.
VYKAT XR is expected to be available in the U.S. Starting in April 2025, with an annual average cost of $466,200, and Soleno has also launched Soleno One, a patient support program accessible through VykatXR.com, to support patient access, though a late-stage trial showed mixed results regarding statistically significant changes in hyperphagia compared to a placebo group.

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PANTHERx® Rare Selected by Soleno Therapeutics for the Distribution of VYKAT™ XR

PITTSBURGH, March 28, 2025 /PRNewswire/ -- PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce that it was selected by Soleno Therapeutics as the specialty pharmacy for the…

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FDA OKs First Drug for Hyperphagia in Prader-Willi Syndrome

(MedPage Today) -- The FDA approved extended-release diazoxide choline (Vykat XR) to treat the intense persistent sensation of hunger in patients 4 years of age and older with Prader-Willi syndrome, maker Soleno Therapeutics announced. "The FDA...

6 days ago·New York, United States

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Soleno Therapeutics' 'life-changing' rare-disease drug approved

The FDA Wednesday approved the first drug to treat people with Prader-Willi syndrome, a rare genetic disease that causes an insatiable desire to eat.

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First Drug Approved for Hyperphagia in Prader-Willi Syndrome

Soleno Therapeutics has announced that the FDA has approved VYKAT XR (diazoxide choline) extended-release tablets for the treatment of hyperphagia in adults and children 4 years of age and older with Prader-Willi syndrome (PWS). Hyperphagia is the defining symptom of PWS. It is a chronic and life-threatening condition characterized by an intense persistent sensation of hunger. “The approval of VYKAT XR is a significant milestone for Soleno and,…

5 days ago

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