Vanda up as it gets FDA nod for sleep disturbances drug

Shares of Vanda Pharmaceuticals (Nasdaq: VNDA) closed up 9.3% at $13.49 on Wednesday, after it revealed that the US Food and Drug Administration has approved Hetlioz (tasimelteon) capsule and liquid formulations for the treatment of adults and children, respectively, with night-time sleep disturbances associated with Smith-Magenis syndrome (SMS).

SMS is a rare neurodevelopmental disorder, a defining feature of which is an "inverted" circadian rhythm, making it extremely difficult for patients with SMS to sleep during the night. Hetlioz is the first FDA-approved medication for patients with SMS.

"The FDA approval of Hetlioz for the treatment of night-time sleep disturbances in SMS would not have been accomplished without the heroic efforts of SMS patients and the efforts of their families and advocates supporting the recruitment, design, and conduct of the study," said Dr Mihael Polymeropoulos, Vanda's president and chief executive.