UCB narcolepsy and cataplexy treatment gets positive CHMP opinion

UCB has announced that Xyrem (sodium oxybate), its treatment for narcolepsy with cataplexy, has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMEA).

The opinion recommends that the agency grants marketing authorisation for the compound to treat patients with this condition, with a decision from the European Commission expected to be made within six weeks.

Xyrem contains the active ingredient hydroxybutyrate, a sodium salt of gamma for the treatment of narcolepsy, a neurological condition whose symptoms include excessive daytime sleepiness, fragmented sleep during the night and cataplexy, the sudden loss of muscle tone.

Troy Cox, president of central nervous system operations at UCB, said: “This positive opinion is encouraging news and we now look forward to the opportunity of making Xyrem available to more patients in Europe with this sleep disorder.”

He added that if the compound were to receive this expanded indication, it would become the first compound so approved by the EMEA.

In October 2006, UCB and Jazz Pharmaceutical announced that it had signed an expanded product license agreement for Xyrem to enable UCB to commercialise the compound for the treatment of fibromylagia syndrome.