EMA to Review Merck KGaA’s MS Tablets MAA

The European Medicines Agency (EMA) has agreed to review Merck KGaA’s Marketing Authorization Application (MAA) for its investigational Cladribine Tablets product recommended for treatment of relapsing-remitting multiple sclerosis (MS). Merck’s submission includes data from three phase 3 studies and one phase 2 study. In these trials, the company said the 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, 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. The submission demonstrates Merck’s continued commitment to fighting the devastating disease of multiple sclerosis, said Luciano Rossetti, head of Global R&D for the company’s Biopharma business.

“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,” said Rossetti, adding: “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.”