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Merck KGaA hopes for drug approval


Merck KGaA has submitted its multiple sclerosis tablet Cladribine for US government approval.

The drug, which would be used to treat relapsing forms of MS, has been allowed “priority review” designation by the US Food and Drug Administration which means its review period is shortened to six months instead of the usual 10.

Drugs deemed to have the potential to significantly advance treatment of a given condition are usually fast-tracked in this way.

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The panel is expected to make a decision on Cladribine by the end of the year.

Fereydoun Firouz, who runs Merck KGaA’s US affiliate EMD Serono, said: “This is a critical milestone on the path to potential approval for short course therapy with Cladribine tablets, moving us one step closer to meeting an unmet need as an oral, disease-modifying drug available for relapsing MS.”

Copyright Press Association 2010

US Food and Drug Administration

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