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Wakix backed for European approval in narcolepsy

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

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



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