Keywords: Merck KGaA, cladribine, FDA approval delay

US FDA delays Merck KGaA’s filing on MS drug cladribine

Article | 1 December 2009

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In a move that will delay the approval of German drug major Merck KGaA’s multiple sclerosis drug cladribine, the US Food and Drug Administration has issued a “refuse to file” letter on the firm’s New Drug Application for the compound as a therapy for relapsing forms of MS.

Merck’s shares fell 4.5% to 62.54 euros by 14.00 GMT on November 30, the leading decliner among German blue chips stocks.

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“The company will work closely with the FDA to fully understand FDA's concerns and define a path forward for a successful resubmission of this application at the earliest point in time,” said Elmar Schnee, executive board member of Merck and head of the Merck Serono division. “We remain focused on delivering on our promise to transform the way people living with multiple sclerosis approach their therapy options,” he added.

Merck filed its NDA in September, ahead of Swiss rival Novartis’ submission which is expected in Europe and the USA at the end of this year, for FTY720. The German firm had previously said it expected to launch cladribine in the second half of 2010, which now looks most unlikely.

Based on current regulations, once a NDA is submitted to the FDA, the agency has 60 days to preliminarily review the submission and assess whether it is sufficiently complete to permit a substantive review. If it determines that the NDA is not sufficiently complete, the FDA issues a refuse to file letter to the applicant. Merck Serono plans to request a meeting with the FDA as soon as possible to discuss what would be required for the cladribine NDA to be accepted for review.