Back to previous

EU Turns Down Fibromyalgia Drug

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.

We do not endorse any research, studies or sources mentioned within our blogs and comments. Furthermore, we do not endorse any medical advice provided, and would strongly recommend anyone seeking medical advice to contact their local healthcare provider.

To start your claim

Get in touch

Request A Callback

To hear what our clients say about us

Visit our testimonials

Read more

Leave a comment

Your email address will not be published. Required fields are marked *

Related Posts