Belgium’s UCB says that it has received the go-ahead in Europe for a new indication of its narcolepsy treatment Xyrem.
The European Commission has approved Xyrem (sodium oxybate) for the treatment of narcolepsy with cataplexy in adults and the company noted that the drug is the first approved medicine on the continent for this indication.
Narcolepsy typically begins with excessive daytime sleepiness during the second and third decades of life, progressing to include disturbed night-time sleep, cataplexy (muscle weakness), sleep paralysis and hypnagogic hallucinations. In a UCB statement, Prof Gert Jan Lammers of the Leiden University Medical Centre in the Netherlands noted that “a large number of patients require the administration of several medicines to control the core symptoms of narcolepsy [and] with this new approval, Xyrem offers physicians and a substantial number of patients a single treatment option.”
Last year, UCB announced an extension to its Xyrem licence agreement with Jazz Pharmaceuticals, which doubles the number of countries where UCB has commercialisation rights to the drug, and includes rights to Xyrem in the treatment of fibromyalgia “if and when the product is approved for this indication.” Jazz has been selling the product in the USA since 2002.