US FDA okay's Merck KGaA's reworked MS pill application

The US Food and Drug Administration (FDA) accepted a reworked request by Germany's Merck KGaA for regulatory approval of cladribine, a key pipeline drug for the pharmaceuticals and chemicals company. The move puts Merck back in the race against rival Novartis to market a pill for multiple sclerosis in the United States. The application was granted a priority review status by the FDA, with the goal of a completing the review in six months instead of the standard 10 months, Merck said on Wednesday.

Merck expects the FDA to decide on marketing approval for cladribine in the last three months of this year, it added. The family-controlled drugmaker resubmitted the US application for its MS pill on June 8, trying to catch up with Novartis, which remains on track to bring the first oral treatment against the debilitating disease to market. Novartis's rival product Gilenia already has priority review status with the FDA. The drug is likely to be approved to treat US patients with relapsing multiple sclerosis as early as the third quarter. Only injectable drugs are now on offer to treat MS, in a market worth about $8.6Bn per year, with the main products offered by Biogen Idec Inc, Bayer AG, Novartis and Teva.