Merck KGaA's Cladribine Multiple Sclerosis Pill Gets Faster Review in U.S.

Merck KGaA said U.S. regulators granted the cladribine multiple sclerosis pill priority review, reducing to six months from 10 the time it will take the Food and Drug Administration to decide on approval.

The regulator is expected to rule on the treatment in the fourth quarter, the Darmstadt, Germany-based maker of drugs and chemicals said in a statement on its website today.

Merck lags behind Novartis AG in the race to provide MS patients with a pill in the U.S., where the Swiss drugmaker won a regulatory panel’s backing on June 10 for its Gilenia tablet. The two medicines will compete with injectable drugs such as Teva Pharmaceutical Industries Ltd.’s Copaxone, Biogen Idec Inc.’s Avonex and Merck’s own Rebif, the top-selling drug in the company’s pharmaceutical division.

Merck won approval to sell cladribine in Russia on July 12 and said it expects to start selling the medicine there early next year. The company said June 8 it had resubmitted its U.S. application for the MS pill. The FDA rejected Merck’s first submission in November, saying it was incomplete.

Novartis said on July 15 it expects a positive opinion from European regulators by the fourth quarter for Gilenia.

To contact the reporter on this story: Naomi Kresge in Zurich at nkresge@bloomberg.net

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