EMA advisory says no to UCB's Xyrem for fibromyalgia

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) yesterday told Belgian drugmaker UCB (Euronext Brussels: UCB) that Xyrem (sodium oxybate) will not be recommended as a treatment for fibromyalgia syndrome in adults in the European Union.

"Upon discussions and following oral explanation with the CHMP, we have to accept that Xyrem in fibromyalgia syndrome will not be recommended for approval in the EU near-term. We are very disappointed with the CHMP decision given the significant unmet medical need in fibromyalgia syndrome in Europe today and the consistently positive Phase III clinical trials with Xyrem in the indication," said Iris Loew-Friedrich, chief medical officer of UCB.

No medication has been approved in Europe to date for the treatment of fibromyalgia which is a chronic disease characterized by widespread pain. In the EU, sodium oxybate is approved for the treatment of narcolepsy with cataplexy in adult patients and is marketed by UCB under a license from the USA’s Jazz Pharmaceuticals, which also has failed so far to gain Food and Drug Administration approval for the fibromyalgia indication.