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CHMP gives negative opinion for Cladribine

European regulator rejects Merck's oral treatment for relapsing-remitting MS

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a negative opinion regarding the marketing authorisation application (MAA) for Merck's cladribine (leustatin) tablets as a treatment for relapsing-remitting multiple sclerosis (MS).

The CHMP stated that, based on currently available data, it does not believe that the benefits of cladribine outweigh its risks. Of particular concern to the regulator were the cancer cases witnessed during clinical trials of cladribine and the damping down effect it has on the immune system.

The negative opinion came just days after the US Food and Drug Administration (FDA) approved Novartis' MS pill Gilenya (fingolimod) as a first line treatment for patients with relapsing forms of MS. This decision places Novartis ahead of Merck in the race to bring the first oral treatment to market. However, Gilenya is still under review and yet to be approved in Europe.

In response to the CHMP's announcement, Merck has affirmed its committment to making cladribine tablets available to MS patients in Europe. The company said it is evaluating all options to gain approval in the European Union, including a potential appeal to request re-examination of the submission by the CHMP, in accordance with the current European regulatory legislation. 

Cladribine tablets were approved in Australia and Russia recently as a treatment of relapsing-remitting MS under the trade name Movectro and are under regulatory review in other countries, including the US where the application has been granted priority review by the FDA.

27th September 2010

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