Merck Receives EMA Acceptance for Review of Marketing Authorization Application for Cladribine Tablets
Merck announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the investigational product Cladribine Tablets for the treatment of relapsing-remitting multiple sclerosis (MS).
“Our submission of the Marketing Authorization Application for Cladribine Tablets demonstrates Merck’s continued commitment to fighting the devastating disease of multiple sclerosis,” said Luciano Rossetti, Head of Global R&D for the Biopharma business of Merck. “Although there are multiple therapies available for relapsing-remitting MS, there is still a significant unmet medical need with a focus on efficacy, dosing, durability and safety. We believe that Cladribine Tablets, if approved, would have a first-of-its-kind dosing regimen and serve as an important therapeutic option for patients with relapsing-remitting MS.”
The MAA submission includes data from three Phase III studies, CLARITY, CLARITY EXTENSION and ORACLE MS, and the Phase II ONWARD study. In these trials, Cladribine Tablets showed significantly reduced relapse rates, risk of disability progression and development of new MS lesions, as detected by MRI, versus placebo in patients with relapsing-remitting MS. Together with interim long-term follow-up data from the prospective registry, PREMIERE, the new MAA also includes follow-up consisting of over 10,000 patient years of exposure in total, with follow-up in some patients exceeding eight years.
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