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The European Medicines Agency will not recommend Xyrem as treatment for fibromyalgia syndrome in adults.
UCB made the announcement today after it was informed of the decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
“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,” said Prof. Iris Loew-Friedrich, Chief Medical Officer, UCB.
“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 3 clinical trials with Xyrem® in the indication.”
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 European Union, sodium oxybate is approved for the treatment of narcolepsy with cataplexy in adult patients and is marketed by UCB under a license from Jazz Pharmaceuticals.