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Merck Serono MS pill wins priority review

Merck Serono has been granted a priority review in the US for cladribine – potentially the country's first oral therapy for relapsing multiple sclerosis

Merck Serono has been granted a priority review by the US Food and Drug Administration (FDA) for cladribine tablets, which the company aims to market as the first orally delivered therapy for relapsing forms of multiple sclerosis (MS).

The priority review designation, which is reserved for drugs that have the potential to provide significant advances in treating serious conditions, means that the FDA has set a six-month goal for reviewing the new drug application (NDA) rather than the usual 10-month goal.

The faster review could help the company make up the time that it lost late last year, when the FDA refused to accept the initial marketing application for the tablets, sending it back to Merck for more information and delaying the drug's planned timeline. The NDA has now been accepted for filing, and the FDA plans to make a decision in the fourth quarter of 2010.

The NDA is supported by results from Merck's two-year CLARITY clinical trial, the results of which were published in the New England Journal of Medicine in February.

The study randomised 1,326 patients with relapsing-remitting MS to one of three different treatment groups consisting of two different dose regimens of cladribine or placebo. Results showed a short-course treatment with orally delivered cladribine significantly reduced MS relapse rates.

Injectable versions of cladribine are already approved in the US to treat symptomatic hairy cell leukaemia. Cladribine tablets were cleared for marketing for relapsing MS in Russia in July, marking the oral product's first regulatory approval. All in all, Merck Serono has filed marketing applications for the tablets covering 40 countries.

28th July 2010


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