FDA approves Hetlioz, first treatment for non-24 hour sleep-wake disorder in blind people

The US Food and Drug Administration on Friday approved US drugmaker Vanda Pharmaceutical's (Nasdaq: VNDA) Hetlioz (tasimelteon), a melatonin receptor agonist, to treat non-24- hour sleep-wake disorder (“non-24”) in totally blind individuals.

Non-24 is a chronic circadian rhythm (body clock) disorder in the blind that causes problems with the timing of sleep. This is the first FDA approval of a treatment for the disorder, and follows a 10 to 0 vote from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (The Pharma Letter November 15, 2013).

Vanda in-licensed tasimelteon from Bristol-Myers Squibb in 2004 under a $41million deal, and last year B-MS waived its option to re-acquire rights. News of the approval pushed Vanda’s share up as much as 15%, but the stock settled back for a 1.3% rise to $13.23 by close of trading on January 31.