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EMD Serono Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application
Date:11/30/2009

ROCKLAND, Mass., Nov. 30 /PRNewswire/ -- EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that it received a refuse to file letter from the US Food and Drug Administration (FDA) on the New Drug Application (NDA) for Cladribine Tablets, EMD 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, Member of the Executive Board Merck KGaA and Head of Pharmaceuticals. "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. EMD 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.

About Cladribine Tablets

EMD Serono's oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS.

The clinical development program for Cladribine Tablets includes:

  • The CLARITY (CLAdRIbine Tablets Treating MS OrallY) study and
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SOURCE EMD Serono, Inc.
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