STAT+: 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. 

Mar 27, 2025 - 00:19
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STAT+: Soleno Therapeutics’ ‘life-changing’ rare-disease drug approved

The Food and Drug Administration on Wednesday approved the first medicine to treat people with Prader-Willi syndrome, a rare genetic disease that causes an insatiable desire to eat. 

The drug, a once-daily pill called Vykat XR, was developed by Soleno Therapeutics. 

“The approval of Vykat XR is a significant milestone for Soleno and, most importantly, for the PWS community who have had no options to treat the most disruptive aspect of this disease,” said Soleno CEO Anish Bhatnagar.

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