European regulators have turned down Xyrem as a treatment for fibromyalgia.
UCB, which markets Xyrem in the European Union has now been informed by the CHMP (The Committee for Medicinal Products for Human Use) that the treatment will not be recommended as a treatment for fibromyalgia.
Iris Loew-Friedrich, chief medical officer at UCB said that “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”. She added that the firm is very disappointed with the decision given the significant unmet medical need “and the consistently positive Phase III clinical trials with Xyrem in the indication”.
No medication has been approved in Europe to date for the treatment of fibromyalgia and a recent bid to get approval for Xyrem in the US failed last October.
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