Belgium’s UCB says that it is expecting to win final European approval for Xyrem (sodium oxybate) in the treatment of cataplexy in adults with narcolepsy some time during the fourth quarter of 2005 after winning the backing of the European advisory body, the CHMP, yesterday.
The company notes that once Xyrem is given final clearance, it will be the first drug approved to treat the sudden loss of muscle tone associated with the serious sleep disorder, narcolepsy, in most EU countries.
Narcolepsy is a serious sleep disorder affecting about 200,000 people in the European
Union. Cataplexy is a typical symptom of narcolepsy, second in frequency only to excessive daytime sleepiness. Cataplexy is a sudden loss of control over voluntary muscles, triggered by emotions such as amusement, anger, arousal or fear. Severe cataplexy attacks can cause complete postural collapse. Cataplexy places a high burden on affected patients: not only can sudden cataplexy lead to accidents and injuries but it can mean embarrassment and persistent psychosocial distress and thus severely impact patients’ quality of life.
Celltech, which was bought by UCB for £1.5 billion pounds last year [[18/05/04a]], acquired the license to distribute Xyrem in Europe from Orphan Medical back in October 2002 [[30/10/03f]]. The latter company has been distributing Xyrem in the USA since its approval there in 2002 [[18/07/02b]].
Clinical trial data showed that Xyrem reduced cataplexy attacks by up to 69% within four weeks of treatment. Furthermore, 80% of patients receiving Xyrem daily were rated as “much” or “very much improved” by investigators, versus 32% of placebo-treated patients. Continuation of treatment for 12 months revealed that the results were maintained in long-term treatment with no evidence for development of tolerance.