Soleno Gets FDA Approval for Hyperphagia Drug

Dow Jones
03-27

By Katherine Hamilton

Soleno Therapeutics gained approval from the Food and Drug Administration for its hyperphagia drug.

The biopharmaceutical company focused on treating patients with rare diseases said Wednesday it got approval for Vykat XR, which is intended to treat hyperphagia in adults and children over four years old with Prader-Willi syndrome.

Prader-Willi syndrome is a genetic disorder. A hallmark of the disease is hyperphagia, an intense and persistent sense of hunger.

Soleno expects the drug to be available in April, it said.

The approval was based on a study and safety data from a comprehensive clinical development program.

Write to Katherine Hamilton at katherine.hamilton@wsj.com

(END) Dow Jones Newswires

March 26, 2025 17:28 ET (21:28 GMT)

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