Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Conversis

Conversis is a translation company specialising in translation and localisation for the Life Science and Pharmaceutical industry, with particular focus...

Latest intelligence

A uniquely English genomic medicine service
The UK National Health Service is developing one standardised approach to embedding precision medicine across the whole of England. Blue Latitude Health speaks to Dr Tom Fowler, Deputy Chief Scientist...
Blended Intelligence
Data is the most valued commodity of the modern world. For P&P it's all about the application....
The relevance of patient perspectives to value: Patient Involvement in Health Technology Assessment
Exploring the evolution of patient involvement in health technology assessment (HTA), and the role of the patient voice in market access....

Infographics