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German Merck plans to seek US FDA approval for multiple sclerosis drug

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German Merck plans to seek US FDA approval for multiple sclerosis drug

Merck KGaA plans to seek the U.S. Food and Drug Administration's approval for its multiple sclerosis treatment Mavenclad in the second quarter of 2018, Reuters reported Dec. 14, citing Belen Garijo, the head of the healthcare division.

The company had previously filed for approval in 2011, but the FDA's concerns caused the company to end its development plans for the drug. The company later resumed its plans for the drug, focusing on patients with highly active relapsing multiple sclerosis, and received approval in Europe in August.

Garijo told Reuters that unlike Roche Holding AG's Ocrevus, which is an infusion drug, Mavenclad was not developed for treating primary progressive multiple sclerosis.