FDA advisory committee recommends approval of Vanda Pharmaceuticals' Hetlioz for non-24-hour disorder in the totally blind

Drug would be first approved to treat circadian rhythm disorder also known as non-24

WASHINGTON — A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

Vanda Pharmaceuticals said the FDA's Peripheral and Central Nervous System Drugs Advisory Committee had voted overwhelmingly to recommend approval for Hetlioz (tasimelteon), a drug for non-24-hour disorder. Non-24-hour disorder, also called non-24, is a chronic disorder characterized by the inability to synchronize the body's internal clock with a 24-hour day-night cycle, affecting between 65,000 and 95,000 totally blind people.

"We are extremely pleased that the FDA's advisory committee has recommended that the FDA approve Hetlioz for the treatment of non-24 in the totally blind," Vanda president and CEO Mihael Polymeropoulos said. "We are now one step closer toward our goal of providing a treatment option that addresses the physiologic cause of this serious, debilitating orphan condition that impacts a majority of totally blind individuals."

The drug has priority review status from the FDA, which the agency grants to drugs that, if approved, would mark a significant improvement over existing treatments; there is currently no FDA-approved treatment for non-24. An advisory committee vote in favor of recommending approval does not guarantee the FDA will approve a drug, but the agency usually follows advisory committee votes.


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