As expected, advisors to the US Food and Drug Administration have recommended approval of Vanda Pharmaceuticals' tasimelteon, to be sold as Hetlioz, for the treatment of non-24-hour disorder in the totally blind.
The agency's Peripheral and Central Nervous System Drugs Advisory Committee has voted 10-0, with one abstention, in terms of efficacy and voted unanimously that safety has been shown for the circadian regulator. Non-24 affects the majority of the 65,000 and 95,000 totally blind people in the USA who lack the light sensitivity necessary to synchronise the body clock in the brain with the 24-hour day-night cycle.
There are no approved treatments for non-24 and the agency granted tasimelteon a priority review in July. It has a Prescription Drug User Fee Act date of January 31, but the FDA is expected to give the full thumbs-up before then.
The panel's backing came as no surprise given that earlier in the week FDA staffers had been glowing in their praise of the treatment.