FDA Staff Says bloomberg.com
Vanda Pharmaceuticals Inc.’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 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.
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.