Vanda Pharmaceuticals Inc. (VNDA)’s experimental drug should be approved to regulate the circadian rhythms of blind people and help them sleep, a U.S. regulatory reviewer said. The shares jumped 96 percent.
The medicine, known as tasimelteon, is effective at synchronizing the body with a 24-hour cycle, Food and Drug Administration staff said today in a report ahead of a Nov. 14 meeting of agency advisers. The drugmaker climbed to $13.30 at the close in New York, its biggest increase since May 2009. The shares have more than quadrupled in the last 12 months.
No approved treatments exist for the condition called non-24-hour disorder, which affects as many as 95,000 totally blind people in the U.S, Vanda said. Most people have a master body clock that naturally runs longer than 24 hours and light resets the clock, according to the Rockville, Maryland-based company.
Patients with non-24-hour disorder now try the hormone melatonin with mixed results. Vanda studied its compound’s ability to “entrain” or modify circadian rhythms.
The FDA is expected to decide whether to approve tasimelteon, which Vanda has proposed calling Hetlioz, by Jan. 31. Vanda’s only FDA approved product, Fanapt for schizophrenia, is licensed to Novartis AG (NOVN) in the U.S.
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