Tasimelteon, a melatonin-receptor agonist available in the United States, is getting closer to becoming available in the European Union to help regulate sleep patterns in blind people.
On April 24, the European Medicines Agency (EMA) announced that the Committee for Medicinal Products for Human Use (CHMP) had recommended granting authorization for marketing of the drug in the European Union for non-24-hour sleep-wake disorder in “totally blind” adults. Once marketed, this would be the first treatment in Europe for this indication, which the statement describes as a rare and “long-term debilitating condition.”
The drug was shown to be effective in two clinical trials, the results of which showed that treatment resulted in significant improvement, compared with placebo, “both in increasing night-time sleep and decreasing daytime sleep duration,” according to the statement. Headache, drowsiness, and nightmares or “unusual dreams” were among the most common adverse effects associated with treatment.
Tasimelteon was approved in the United States in January 2014 for treating non-24-hour sleep-wake disorder, referred to as “non-24,” at a dose of 20 mg taken before bedtime at the same time every night.
“The precise mechanism by which tasimelteon exerts its therapeutic effect” in patients with non-24 is not known, according to the U.S. prescribing information, which adds that the drug is an agonist at melatonin MT1 and MT2 receptors, which are thought to be involved in the control of circadian rhythms.
The trade name used in the EMA release is Hetlioz, the trade name used in the United States.
The EMA is similar to the FDA and the EMA’s CHMP committee prepares opinions on questions related to medications used to treat humans.
The CHMP opinion, adopted at a meeting in April, will be sent to the European Commission for a decision on marketing authorization in the EU. After authorization for marketing has been granted, the decision about cost and reimbursement “will then take place at the level of each Member State considering the potential role/use of this medicine in the context of the national health system of that country,” the EMA release stated.
The drug is manufactured by Vanda Pharmaceuticals.
