Vanda Pharmaceuticals Inc. won U.S. approval for the first drug to regulate the circadian rhythm of blind people to help them sleep.
The Food and Drug Administration cleared the drug, Hetlioz, for a condition called non-24-hour disorder, which affects about 80,000 blind people in the U.S., the Washington-based company said today in a statement. The medicine, also known as tasimelteon, synchronizes the body with a 24-hour cycle.
No other approved treatments exist for the condition. Circadian rhythm is the body’s biological timekeeper, sending signals for when to eat or sleep based on light. Blind people who can’t rely on the natural light cue have trouble falling asleep at night and resisting the urge to sleep during the day.
“We’re very pleased to hear that the drug has been approved and we’re very hopeful that it will be of benefit to blind people who have this disorder,” Chris Danielsen, spokesman for the National Federation of the Blind, said in a telephone interview. The group is helping Vanda inform blind people about the medicine, he said.
Patients with non-24-hour disorder have used the hormone melatonin with mixed results. Hetlioz increased sleep by 57 minutes per day during the worst 25 percent of nights and decreased naps by 45 minutes a day in the worst 25 percent of days, Vanda said when the company presented data from a final-phase study in June. Hetlioz should be commercially available in the second quarter of 2014, the company said in the statement.
‘Take for Granted’
“Non-24-hour sleep-wake disorder can prevent blind individuals from following the normal daily schedule that we all take for granted,” Eric Bastings, deputy director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, said in a statement. “Hetlioz can improve the ability to sleep at night and to be active during the day.”
The most common side effects of the drug in clinical trials were headache, elevated liver enzymes that can signal damage to the organ, nightmares, drowsiness and upper respiratory or urinary tract infections. The FDA granted Hetlioz orphan drug status because it treats a rare disease, a designation that affords Vanda an additional seven years to sell the medicine free from generic competition.
Vanda gained 1.3 percent to close at $13.23 in New York. The company’s shares more than tripled last year as investors made bets on the sleep drug’s potential for approval. Vanda’s only other FDA-approved product, Fanapt for schizophrenia, is licensed to Novartis AG in the U.S.