EMD Serono, the biopharmaceutical business of Merck KGaA, Darmstadt, Germany, in the U.S. and Canada, has 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).
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
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.
The NDA acceptance follows global approvals of cladribine tablets under the trade name MAVENCLAD® in 38 countries since August 2017, including the European Union (EU), Canada, Australia, Israel, Argentina, United Arab Emirates, Chile and Lebanon.
Cladribine is an investigational agent that has been studied as a short-course (a maximum of 20 days of treatment over two years) oral therapy that is thought to selectively target lymphocytes, which may be integral to the pathological process of relapsing MS.
The clinical development program included data from three Phase III trials, CLARITY, CLARITY EXT and ORACLE MS, the Phase II ONWARD study and long-term follow-up data from the eight-year prospective registry, PREMIERE.
Belén Garijo, Member of the Executive Board and CEO Healthcare of Merck KGaA, Darmstadt, Germany said, “We are delighted the FDA has accepted cladribine tablets for filing. 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.”
Thomas Leist, M.D., PhD, Director, Comprehensive Multiple Sclerosis Center at Jefferson University Hospitals said, “Most available MS therapies require continued, regular dosing of medication. A treatment approach consisting of short, infrequent oral treatment cycles may help lower the treatment burden for patients.”