The European Medicines Agency is recommending the use of the narcolepsy medicine pitolisant in Europe, according to the Pharmaceutical Journal.
The first drug of its kind to treat patients with the rare but long-term sleep disorder narcolepsy is being recommended for use across the European Union (EU).
The European Medicines Agency (EMA) is recommending that pitolisant (Wakix) is granted a marketing authorisation for the treatment of narcolepsy with or without cataplexy — sudden severe muscle weakness or loss of muscle control.
The drug, a first-in-class medicine, is an antagonist of the histamine H3 receptor, leading to an increase in histamine release in the brain, which in turn enhances wakefulness and alertness.
The recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) is based on the results of two 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.