Please login to the form below

Not currently logged in
Email:
Password:

Wakix backed for European approval in narcolepsy

Bioprojet Pharma’s orphan drug given a positive opinion by CHMP
EMA

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended Bioprojet Pharma's Wakix for the treatment of narcolepsy with or without cataplexy.

The CHMP opinion follows safety and efficacy data for Wakix (pitolisant) from four studies using 466 patients showing that Wakix was effective at reducing daytime sleepiness in patients with narcolepsy.

The drug was also shown to be beneficial for patients with cataplexy (sudden severe muscle weakness or loss of muscle control).

Narcolepsy is a rare, long-term sleep disorder, which affects the brain's ability to regulate the normal sleep-wake cycle. This can lead to symptoms such as excessive daytime sleepiness including the sudden urge to sleep as well as disturbed night-time sleep.

Wakix works by acting on histamine H3 receptors in the brain, leading to increasing histamine release in the brain thereby enhancing wakefulness and alertness.

Wakix received orphan designation from the committee for orphan medicinal products (COMP) in 2007, allowing it to qualify for ten years of market exclusivity as well as grant the developers access to key incentives such as fee reductions.

In addition to the recommendation, the CHMP also requested Bioprojet Pharma carry out a long-term safety study in order to further investigate the safety of the medication when used in patients over a long period of time. 

Article by
Nikhil Patel

20th November 2015

From: Regulatory

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Clark Health Communications

Clark Health Communications (CHC) is an independent, award-winning health and medical communications agency. Our collaboration with experts and advocates enhances...

Latest intelligence

International Childhood Cancer Day 2019
The number of new cases per year is shocking but the journey and the outlooks have vastly improved. We've pulled together an infographic to show just what we mean with...
Immuno-oncology in 2019: the rapid evolution continues
Immunotherapy is pharma’s biggest growth driver – how will it develop in 2019?...
Mixing up Focus Groups
A nice spread of homogeneous participants in a focus groups are often a go to for reliable research outcomes but there's much to be said for mixing it up and...

Infographics