News Feature | June 9, 2014

EMA Accepts Vanda's Sleep Disorder Drug MAA

By Estel Grace Masangkay

Vanda Pharmaceuticals, a biopharmaceutical company focused on developing treatments for central nervous system disorders, announced that the European Medicines Agency has accepted its Marketing Authorization Application (MAA) for its oral Hetlioz (tasimelteon) capsules as treatment for Non-24-Hour Sleep-Wake Disorder (Non-24).

Hetlioz is a melatonin receptor agonist indicated for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24). The drug may cause somnolence, and adverse reactions such as headaches, upper respiratory or urinary tract infection, nightmares, and increased alanine aminotransferase.

The drug has received orphan drug designation from the European Commission for the treatment of Non-24 in blind people who have no light perception. The U.S. Food and Drug Administration (FDA) has approved the drug earlier in January this year.

Mihael Polymeropoulos, Vanda's president and CEO, said, “The EMA submission is an important milestone towards providing a treatment option for people living with Non-24 in the European Union. This continues our efforts to expand the availability of Hetlioz to markets outside the U.S.”

Non-24 is a chronic, circadian rhythm disorder caused by the misalignment of the endogenous master body clock to the 24-hour day, which results in the disruption of the normal sleep-wake cycle. The disorder can affect or impair normal function in social, occupational, and other areas of daily life. Non-24 is estimated to affect around 130,000 people in the EU and a majority of totally blind patients.

Earlier this year, Vanda launched the Non-24 Share More Campaign to draw attention to and educate the general public and medical professionals about the disorder. The national initiative was conducted in partnership with Erik Weihenmayer, the only blind person to climb Mount Everest and a known global adventurer. Weihenmayer said his symptoms have led him to believe that he is one of the many blind Americans afflicted with the disease, which affects an estimated 80,000 people in the U.S.

The company announced that it has presented data for the drug at SLEEP 2014, the 28th Annual Meeting of Associated Professional Sleep Societies in Minneapolis, Minnesota.