U.S. FDA review supports Vanda's sleep disorder drug
Nov 12 (Reuters) - An experimental sleep disorder drug made by Vanda Pharmaceuticals Inc is safe and effective enough to warrant approval, a U.S. Food and Drug Administration review found.
The report, posted on the FDA's website on Tuesday, comes two days ahead of a meeting of outside medical experts who will discuss the drug and recommend whether or not it should be approved. The FDA is not bound to follow the advice of its advisory panels but typically does so.
The drug, tasimelteon, is designed to treat Non-24-Hour Disorder, or Non-24, a circadian rhythm disorder that is most commonly found in the totally blind and can cause disrupted nighttime sleep patterns and excessive daytime sleepiness.