FDA clears first drug for blindness sleep disorder

U.S. health regulators have approved a first-of-a-kind drug to treat a sleep disorder that mainly afflicts the blind.

The Food and Drug Administration approved Hetlioz capsules for patients who have problems sleeping because they can't detect light. The condition, called non-24-hour disorder, is estimated to affect up to 100,000 Americans, most of whom are totally blind. Hetlioz is the first FDA-approved treatment for the condition.

The most common side effects of the drug include headache, nightmares and respiratory and . The drug labeling warns that Hetlioz causes drowsiness and can interfere with performing basic tasks and mental alertness.

Analysts estimate the drug's annual sales could exceed $350 million.

Washington DC-based Vanda Pharmaceuticals markets one other drug for schizophrenia.

Company shares rose nearly 5 percent in afternoon trading.

Related Stories

US health watchdog rejects Sanofi's MS drug

date Dec 30, 2013

French drug giant Sanofi announced Monday US health authorities had rejected its Lemtrada drug for some forms of multiple sclerosis, which is already approved in the European Union, Canada and Australia.

Recommended for you

Teva to lift bid for Mylan: report

date 14 hours ago

Israeli pharmaceutical giant Teva plans to increase its bid for rival Mylan and could announce the move as soon as this week, according to a US media report Monday.

Vaccine for West Nile Virus enters human clinical trials

date 18 hours ago

A clinical trial of a new investigational vaccine designed to protect against West Nile Virus infection will be sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes ...

FDA clears drug for leading form of cystic fibrosis

date Jul 02, 2015

Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. But it will ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.