UCB announces EC approval of narcolepsy treatment

UCB has announced that the European Commission (EC) has approved Xyrem (sodium oxybate) as a treatment for adult patients suffering from narcolepsy with cataplexy. The compound becomes the first EC-approved medication of this indication.

The company reports that clinical trials investigating Xyrem involving over 700 patients showed that the compound was well tolerated, while showing efficacy in the treatment of multiple symptoms in narcolepsy patients.

Xyrem was shown to reduce daytime sleepiness, improve the quality of night-time sleep and lower the frequency of cataplexy attacks, while also resulting in clinically relevant improvement in daytime functioning.

Troy Cox, president of central nervous system operations at UCB, said: “The new indication is an important stage in our plans for the development of Xyrem and demonstrates our ongoing commitment to rare orphan diseases.”

He added that patients with narcolepsy can experience a reduced quality of life as a result of the multiple symptoms of the disease, with the company pleased to offer physicians and sufferers a new treatment option for the condition.

Earlier this year, the company reported the issuing of a positive opinion recommending the granting of marketing authorisation for the compound from the Committee for Medicinal Products for Human Use of the European Medicines Agency.