Merck KGaA’s Investigational MS Therapy Cladribine Gets EMA Marketing Authorization Application Review

Patricia Silva, PhD avatar

by Patricia Silva, PhD |

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Merck KGaA, Darmstadt, Germany recently announced that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) of the company’s investigational product Cladribine Tablets as a therapy for relapsing multiple sclerosis (RMS) in Europe.

Cladribine is a synthetic antineoplastic agent able to suppress the immune system, causing relatively few side effects and resulting in very little non-target cell loss.

“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 KGaA in a recent press release. “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 is based on results from three Phase 3 clinical trials: the CLARITY, CLARITY EXTENSION and ORACLE MS, and the Phase 2 ONWARD clinical trial – all in patients with relapsing-remitting MS (RRMS). In the studies, treatment with Cladribine Tablets significantly reduced the relapse rate and the risk of disability progression and development of new MS lesions, compared to placebo.

Together with interim long-term follow-up results from the prospective registry PREMIERE, the new MAA also comprises follow-up data of more than 10,000 patient years of exposure, with some patients having a follow-up period surpassing eight years.

MS is a chronic, progressive neurodegenerative autoimmune disorder that results from an attack on the central nervous system (brain, spinal cord and optical nerves) by the body’s own immune system, ultimately causing motor function impairment, irreversible neurological disability and paralysis. MS usually manifests in younger adults, and it can have a significant impact on the patient’s quality of life. It is estimated that more than 2.3 million people in the world suffer from the disease, including over 120,000 individuals in the United Kingdom, and up to 400,000 in the United States.

RRMS, the most common disease course, is characterized by clearly defined attacks of new or increasing neurologic symptoms. These attacks, also called relapses or exacerbations, are followed by periods of partial or complete recovery (remissions).