EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, today announced that a resubmission of the New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis (MS) has been accepted for filing by the U.S. Food and Drug Administration (FDA).
“We are delighted the FDA has accepted cladribine tablets for filing,” said Belén Garijo, Member of the Executive Board and CEO Healthcare of Merck KGaA, Darmstadt, Germany. “Our goal is to offer cladribine tablets to patients and physicians in the U.S. as a new treatment paradigm for relapsing MS, and we look forward to working closely with the FDA throughout the review process.”
The acceptance indicates that the FDA has found the Company’s resubmission sufficiently complete to permit a substantive review. The resubmission is in response to the Complete Response Letter issued by the FDA in 2011 requesting an improved understanding of safety risks and the overall benefit-risk profile.
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