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REFILE-UPDATE 1-Merck KGaA again seeks U.S. nod for MS pill

(Refiles to fix link to story in paragraph five)

* Move comes amid race for first multiple sclerosis pill

* FDA had held up application in November

* Merck shares indicated flat before German market opens

(Adds details, background)

FRANKFURT, June 8 (Reuters) - Germany's Merck KGaA MRCG.DE has resubmitted its request for U.S. regulatory approval for its cladribine drug as it tries to catch up in the race for the first multiple sclerosis (MS) pill.

Merck in February had said it met with U.S. regulators in January about the approval for cladribine but had so far not given a timetable for resubmitting the drug, which is also under review in Europe.

Merck’s shares were indicated unchanged before the German market opens at 0700 GMT on Tuesday.

Rival Swiss drugmaker Novartis AG NOVN.VX on April 13 moved closer to bringing the first oral MS treatment to market after new data showed its Gilenia pill cut relapse rates in the disease. [ID:nZAT010805]

Gilenia had earlier been given U.S. priority review status. U.S. experts are set to vote this week on whether to recommend approval. [ID:nLDE6530NT]

Merck KGaA had slipped behind Novartis in November after the U.S. Food and Drug Administration held up its application to bring cladribine to market. [ID:nGEE5AT1KS]

Merck had said its bid to bring the pill to European markets remained on track.

The head of Merck’s drug unit, Elmar Schnee, said on April 9 that advisers to European regulators would probably issue an assessment of the drug in the third quarter, adding he was confident about an approval. (Reporting by Ludwig Burger; Editing by Michael Shields)

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