Seven years after it first denied the request, the U.S. Food and Drug Administration accepted for review EMD Serono’s resubmitted New Drug Application (NDA) for cladribine tablets (brand name Mavenclad) as a treatment for patients with relapsing forms of multiple sclerosis (MS).
The regulatory agency agreed EMD Serono’s new application was sufficiently complete, addressing all issues from a Complete Response Letter issued in 2011, including the drug’s safety profile.
Supported by clinical data collected from over 2,700 patients with up to 10 years of safety data, the resubmitted NDA will allow a thorough review of the safety risks and overall benefit-risk profile of the therapy.
This decision to review the NDA was based on results from the drug’s extensive development program, which included three Phase 3 clinical trials — CLARITY (NCT00213135), CLARITY Extension (NCT00641537), and ORACLE-MS (NCT00725985) — the Phase 2 ONWARD trial (NCT00436826), and the ongoing long-term study PREMIERE (NCT01013350).
EMD Serono is the biopharmaceutical business in the U.S. and Canada 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,” Garijo added.
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