Merck KGaA files cladribine for FDA approval

Merck KGaA announced Wednesday that it submitted cladribine for regulatory approval in the US as a treatment for reducing relapses in patients with multiple sclerosis.

The filing for the drug, which the company noted would be the first oral disease-modifying therapy for people with the condition if it is approved, is supported by positive Phase III results from the two-year CLARITY study of more than 1300 patients with relapsing-remitting MS.

Analysts at Piper Jaffray have forecast annual sales of 626 million euros ($916 million) for cladribine if it reaches market. The drug was filed with EU regulators in July.

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