FDA Accepts NDA Resubmission for Oral Cladribine in Relapsing MS
The Agency has deemed the resubmission sufficiently complete for a substantive review.
EMD Serono announced that the Food and Drug Administration (FDA) has accepted the resubmission of the New Drug Application (NDA) for cladribine tablets as a treatment for patients with relapsing multiple sclerosis (MS).
The NDA resubmission is in response to the FDA's Complete Response Letter issued in 2011 which requested an improved understanding of the safety risks and overall benefit-risk profile. The NDA contains data for nearly 12,000 patient-years from >2700 patients included in the Phase 3 clinical program (CLARITY, CLARITY EXT, and ORACLE MS), the Phase 2 ONWARD study, and the long-term follow-up data from the 8-year PREMIERE study. The submission also includes safety data for up to 10 years in some patients. The Agency has deemed the resubmission sufficiently complete for a substantive review.
Cladribine is approved under the brand name Mavenclad in 38 countries. In the US, the investigational tablets are being studied as a short-term oral therapy (maximum 20 days treatment over 2 years) for relapsing MS. The drug is thought to selectively target lymphocytes, which may be critical in the pathology of relapsing MS.
"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. "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 US MS community."
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