Merck KGaA Receives Refuse to File Letter from FDA

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Merck KGaA announced today that its US affiliate received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets

The tablets are Merck Serono’s proprietary investigational oral formulation of cladribine, as a therapy for relapsing forms of multiple sclerosis (MS).

“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.”

Based on current regulations, once a NDA is submitted to the FDA, the Agency has 60 days to preliminarily review the NDA submission and assess whether the NDA 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 its comments on the NDA submission and to reach an understanding on what would be required for the Cladribine Tablets NDA to be accepted for review.