Vanda Pharmaceuticals Inc. (VNDA) won the backing of U.S. advisers for an experimental drug to regulate the circadian rhythms of blind people to help them sleep.
Vanda’s medicine, known as tasimelteon, is effective and safe for use, advisers to the Food and Drug Administration said today in Silver Spring, Maryland. The medication, which the company has proposed calling Hetlioz, is supposed to help synchronize the body with a 24-hour cycle. The FDA isn’t required to follow the recommendations of its advisory panels.
No other approved treatments exist for the condition called non-24-hour disorder, which affects about 80,000 totally blind people in the U.S., Rockville, Maryland-based Vanda said. Most people have a master body clock that naturally runs longer than 24 hours and light resets the rhythm.
“For as long as I can remember I have experienced periods lasting from about 10 days to a couple of months where night after night a full night’s sleep eludes me no matter what I do,” Melanie Brunson, executive director of the American Council of the Blind, told panel members today. “I urge you to give us another option that will let us experience quality sleep at night so we can have full and quality lives during the day.”
The FDA is expected to decide whether to approve Vanda’s drug by Jan. 31. The panel voted 10-0, with one abstention, that Vanda had presented substantial evidence of the drug’s efficacy in non-24 hour disorder. It voted unanimously that the medicine’s safety has been adequately addressed, though some panel members said the studies involved a small number of patients.
“This is a breakthrough,” Michael Vitiello, a panel member, professor and co-director of the Center for Research on Management of Sleep Disturbances at the University of Washington in Seattle, said today, referring to disruptions to circadian rhythms being considered a disorder. “You need only look at the data graphs to see that sleeping at the wrong time can have a profound impact.”
Vanda shares almost doubled Nov. 12 after an FDA reviewer recommended the drug’s approval in a staff report. They were halted today during the committee meeting. The company’s only FDA-approved product, Fanapt for schizophrenia, is licensed to Novartis AG (NOVN) in the U.S.
Patients with non-24-hour disorder now try the hormone melatonin with mixed results. Vanda studied tasimelteon’s ability to “entrain” or modify circadian rhythms.
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