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news.The European Medicines Agency (EMEA) is recommending UCB's Xyrem for marketing approval in the treatment of narcolepsy with cataplexy.
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The European Commission is expected to issue a final decision within approximately six weeks. Xyrem has been designated as an orphan medicinal product. Orphan medicinal products are used to diagnose, prevent or treat life-threatening or rare conditions, with a prevalence of less than five per 10,000 of the EU population.
“With this expanded indication, Xyrem would be the first and only medicine approved by the European Medicines Agency for the treatment of narcolepsy with cataplexy in adult patients,” said Troy Cox, president CNS Operations, UCB.
The effectiveness of Xyrem for the treatment of narcolepsy symptoms has been established in three studies. The long term safety and efficacy of Xyrem for the treatment of narcolepsy has also been evaluated in a 12-month, open-label, multi-center extension trial. The most commonly reported adverse drug reactions are dizziness, nausea, and headache, all occurring in 10% to 20% of patients.