Please login to the form below

Not currently logged in

FDA panel backs sleep pattern drug for blind

Vanda’s Hetlioz intended to improve circadian rhythms in people who cannot see

A drug designed to help blind people maintain sleeping patterns has been recommended for approval in the US.

A Food Drug and Administration (FDA) advisory committee voted unanimously to recommend approval of Vanda Pharmaceuticals' Hetlioz (tasimelteon) for non-24-hour disorder (N24) in the totally blind. The condition is thought to result from the lack of light stimulation for the areas of the brain that govern circadian rhythms.

If approved, Helioz would be the first drug registered for N24, which causes insomnia at night and excessive sleepiness in the daytime and is termed an "invisible disability", with a dramatic impact on the well-being and social functioning of people with the condition.

It is estimated that around 65,000 to 95,000 people in the US are affected by N24, with most totally blind, although it does occur rarely in sighted people. Tasimelteon acts on melatonin MT1/MT2 receptors and is thought to stimulate the brain via the same pathway as sunlight.

The panel concluded not only that the N24 indication was appropriate for an FDA-approved therapy, but also that the clinical trial measures employed by Vanda to demonstrate Hetlioz' safety and efficacy were robust.

The FDA is due to deliver its verdict on Hetlioz by the end of January and - if positive - some analysts have predicted that Helioz could achieve sales of $200m a year or more at peak.

"For the thousands of blind patients with N24, Hetlioz may offer - for the first time in their lives - the ability to live in sync with a 24-hour world," commented Vanda chief executive Mihael Polymeropoulos during the company's third-quarter results call last week.

As a result, they can "fully enjoy the opportunities of education, employment and social interactions in our 24-hour society," he added.

Hetlioz would be Vanda's first self-marketed product and the company has been steadily building up a commercial unit to market the drug if approved by the FDA, establishing contacts with physicians dealing with N24 patients and discussing the new drug with healthcare payers.

"All key leadership positions are filled, across marketing, sales, managed markets and trade, and our current focus is the build-out of the direct customer-facing teams across all groups," noted Polymeropoulos.

Vanda previously developed a schizophrenia treatment called Fanapt (iloperidone) which is licensed in North America to Novartis but has failed to make much headway in the market since its launch in 2010.Vanda withdrew a marketing application for this product in the EU earlier this year.

Article by
Phil Taylor

15th November 2013

From: Sales



COVID-19 Updates and Daily News

Featured jobs


Add my company
Blue Latitude Health

Blue Latitude Health is a creative marketing consultancy. Founded in 2003, our combination of heritage, approach and capability gives us...

Latest intelligence

How innovating study sites can improve patient recruitment efficiency
There are so many ways that clinical trials have innovated over the last few years. There is now a larger focus on making trials more patient-centric, more virtualised, and more...
Avoiding A Series of Unfortunate Events: launch lessons from lockdown
Chris Ross takes a novel look at launch excellence through the lens of COVID-19 and explores how pharma’s launch leaders are rewriting the story...
6 reasons patients drop out of clinical trials and 6 ways to fix it
If you’ve successfully recruited patients for your clinical trial, but one by one, they begin to drop out, then this information could be for you....