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FDA approves sleep disorder drug for blind people

Vanda Pharmaceuticals wins backing for Hetlioz to improve a person’s body clock
FDA headquarters White Oak

The US Food and Drug Administration (FDA) has approved a new orphan drug to help blind people improve their body clock.

Vanda Pharmaceuticals is now allowed to market its drug Hetlioz (tasimelteon) to treat a condition called non-24-hour sleep-wake disorder, which causes problems in the sleep cycle of blind people.

Hetlioz is the first drug approved in the US to treat non-24 – a condition that means people have difficulty falling or staying asleep and can even lead to a reversal in sleep patterns, meaning people need to sleep during the day.

Non-24 affects people who are completely blind as light does not enter the eye, and leaves some unable to synchronise to the natural sleep cycle.

The condition is found in about 80,000 people in the US and, as such, is classified as a rare disease by the FDA. This means Vanda was able to take advantage of a number of development incentives due to the orphan-drug designation for Hetlioz.

The FDA approval follows the recommendation made by an advisory committee to the regulator made in November last year.

The panel voted unanimously in favour of the drug based on phase III data that demonstrated Hetlioz was significantly superior to placebo across a number of sleep and wake parameters, including total sleep time and timing of sleep.

Hetlioz is a melatonin receptor agonist that works by targeting the MT1/MT2 receptors in the brain, mimicking the effects of natural sunlight.

Vanda said it intends to launch the drug in the US in the second quarter of 2014 when it will become the company's first self-marketed product.

Its approval is especially important considering Vanda's decision last year to withdraw the EU marketing application for its schizophrenia drug Fanaptum (oral iloperidone) after the company struggled to satisfy the requirements of regulators.

Article by
Thomas Meek

3rd February 2014

From: Sales

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