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FDA grants orphan drug designation for Prader-Willi Syndrome treatment

Posted on March 3, 2021

The U.S. Food and Drug Administration has granted orphan drug designation to Tesomet (Saniona) for the treatment of Prader-Willi syndrome (PWS), according to a press release.

Prader-Willi syndrome is a rare genetic disease resulting in behavioral and physical issues, including life-threatening obesity due to dysfunctional signaling in the brain’s satiety center.

A Phase 2b study of Tesomet is planned for 2021.

“There is currently no cure for Prader-Willi syndrome and no medicines approved to address the uncontrollable hunger, or hyperphagia, that characterizes this rare disease,” said Rudolf Baumgartner, MD, Chief Medical Officer and Head of Clinical Development at Saniona, in a press release. “Receiving orphan drug designation will help us advance Tesomet as expeditiously and efficiently as possible.”

Read the full press release here.

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