The European Medicines Agency (EMA) has recommended granting marketing authorisation for Wakix (pitolisant) for the treatment of narcolepsy with or without cataplexy
Narcolepsy is a rare, long-term sleep disorder that affects the brain’s ability to regulate the normal sleep-wake cycle.
Some patients with narcolepsy may also experience cataplexy, a related condition, which can cause dangerous falls and increase the risks of accidents.
Wakix will add to the available treatment options for narcolepsy according to the EMA as it acts on histamine H3 receptors in the brain to enhance wakefulness and alertness.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) evaluated the safety, efficacy and quality of Wakix and decided to recommend the authorisation of Wakix for narcolepsy patients with or without cataplexy.
This recommendation was based on the examination of two pivotal placebo-controlled studies involving 259 patients as well as one uncontrolled, open-label study in 102 patients with narcolepsy and one supportive study in 105 patients.
The studies showed that Wakix was effective in reducing excessive daytime sleepiness in patients with narcolepsy and beneficial for patients also suffering from cataplexy.
The decision to recommend Wakix for authorization was adopted by the CHMP at its November 2015 meeting and will now be sent to the European Commission for a decision on an EU-wide marketing authorisation.