New Drug Application for Cladribine Filed and Accepted

Tuesday, July 31, 2018


Cladribine (Mavenclad; EMD Serono, Rockland, MA) is an investigational oral therapy for patients with relapsing forms of multiple sclerosis (MS). The drug has proposed dosing of a maximum of 20 days over 2 years with no additional dosing required in years 3 and 4. This dosing regimen is substantially different from other disease-modifying treatments available and, if approved, provides another option that may help some patients better achieve adherence to treatment.

A new drug application (NDA) filed with US Food and Drug Administration (FDA) has been accepted by the agency indicating that the resubmission is sufficient to permit a substantive review. The resubmission is in response to a 2011 request by the FDA for improved understanding of safety risks and the overall benefit-risk profile.

The NDA includes close to 12,000 patient years of data and up to 10 years of safety data in some patients; cladribine is approved as Mavenclad in 38 countries outside the US.  

"We are delighted the FDA has accepted cladribine tablets for filing," said Belén Garijo, member of the Executive Board and CEO of healthcare of Merck KGaA, Darmstadt, Germany, the parent company of EMD Serono. "Our goal is to offer cladribine tablets to patients and physicians in the US as a new treatment paradigm for relapsing MS, and we look forward to working closely with the FDA throughout the review process."

"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," said Thomas Leist, MD, PhD, Director, Comprehensive Multiple Sclerosis Center at Jefferson University Hospitals and editorial board member of Practical Neurology. "Based on additional clinical research in recent years, we know more about the treatment course, safety, and impact of cladribine tablets across several key measures of MS and hope it will be made available to the MS community in the US."

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