Washington, D.C.-based Vanda Pharmaceuticals Inc. (NASDAQ: VNDA) announced that the European Union (EU) has approved its HETLIOZ (tasimelteon) drug to be used to treat non-24-hour sleep-wake disorder, also known as Non-24, in totally blind adults.
Non-24 is a chronic, circadian rhythm disorder. It disturbs the normal human sleep-wake cycle and mostly affects totally blind people. Disturbed sleep can lead to stress and also affects coordination. In the EU, around 130,000 people have been affected by this disorder.
HETLIOZ resets the sleep order by focusing the drug on the suprachiasmatic nucleus of the brain. The development of the drug was the biggest ever clinical research program conducted on Non-24.
Vanda’s president and CEO Mr. Mihael H. Polymeropoulos stated that, “the European approval of HETLIOZ is an important milestone for the Non-24 patients throughout the European Union who live with this debilitating disorder.”
Now, Vanda is authorised to market HETLIOZ in all 28 EU member states and in European Economic Area members – Iceland, Norway and Liechtenstein.
In the previous announcement, HETLIOZ‘s patent got listed in the U.S. FDA publication known as Orange Book.
Vanda stock is currently trading negative, down -4.22 percent to $11.80, the 52-week range is a low of $8.34 and a high of $15.51. The companies market value is approximately $509 million.
Also, healthcare and pharma industry focused fund- Stonpine Capital Management revealed their investment in 2.32 million shares i.e. 5.5% of VNDA.