Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) won FDA approval for its drug Hetlioz, which helps patients with Non-24 hour sleep-wake disorder (which is often referred to simply as “non-24″), a condition which occurs in some people who are completely blind, according to an FDA press release. Sales of Hetlioz are expected to rise to around $295 million by 2018, according to two analysts who spoke with Reuters. Vanda expects that it will make the drug commercially available by the second quarter of 2014.
The approval of Hetlioz was based on two different efficacy studies; the drug’s safety has been evaluated in more than 1,300 people. Non-24 hour sleep-wake disorder is a chronic circadian rhythm (often called one’s “body clock”) disorder in the blind that causes issues with the timing of sleep; this is the first and only FDA approval of a drug that treats the disorder. The disorder occurs in the blind because light doesn’t enter their eyes, meaning that the eye cannot help the person adjust to the 24-hour light-dark cycle.
Non-24 is a rare condition: it affects between 65,000 and 95,000 people in the U.S., according to Vanda. Most blind individuals are able to perceive light enough to maintain a normal sleep schedule, but for some who are totally blind, Non-24 can cause a myriad of problems; those with the disorder “may have difficulty falling or staying asleep, and may wake up groggy or feeling as if they need more rest.” Other people with the Non-24 “may find their sleep patterns reversed — needing to sleep during the day and to be awake at night,” according to a press release from the FDA.
“Non-24 sleep-wake disorder can prevent blind individuals from following the normal daily schedule that we all take for granted,” Eric Bastings, the deputy director of the Division of Neurology Products at the FDA’s Center for Drug Evaluation and Research said in the FDA’s press release regarding the approval of Hetlioz.
Hetlioz is taken before bed and works by affecting the body’s levels of melatonin, a hormone that’s produced by the pineal gland, a small endocrine gland located in the brain that is crucial in regulating the body’s “master clock.” Hetlioz effectively “resets” that clock, in the same way that it would normally be reset by the light-dark cycle, per Reuters.
Vanda’s shares rose 8 percent to $14.10 this afternoon after initially rising as high as $15.59 on the news following the announcement of Hetlioz’s approval.