EMA Recommends Approval of Pitolisant for the Treatment of Narcolepsy

On November 20, 2015, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended that Bioprojet Pharma’s drug pitolisant (Wakix) be approved for the treatment of narcolepsy with or without cataplexy.

In making its recommendation, the Committee reviewed data from four studies of pitolisant—two placebo-controlled trials (N = 259), one uncontrolled open-label study (N = 102), and one additional study that provided supportive data (N = 105).

Pitolisant is different from any other medication that is currently approved to treat the excessive daytime sleepiness and cataplexy associated with narcolepsy. Through its action on histamine H3 receptors in the brain, this drug increases the release of histamine in the brain, thereby increasing wakefulness and alertness. In one study, pitolisant was also found to slightly decrease the incidence of cataplexy.

Pitolisant will not be immediately available for sale. The next step is for the CHMP opinion to be sent to the European Commission, who will then decide whether to adopt this decision and authorize marketing throughout the European Union. If the European Commission authorizes marketing, each member of the European Union will then decide on whether they will make pitolisant available in their national health system and at what price.

For more information on the role of histamine in controlling wakefulness, please see the August 18, 2015, issue of SomnusNooze, “How GABA and histamine work together to control wakefulness.”

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