The European Medicines Agency (EMA) has granted the review of the Marketing Authorisation Application (MAA) for American pharmaceutical company Merck’s investigational product Cladribine Tablets to treat relapsing-remitting multiple sclerosis (MS).
MS is a chronic, inflammatory condition of the central nervous system that causes non-traumatic, disabling neurological disease in young adults.
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The relapsing forms of MS are the most common among all.
Merck’s Cladribine is an oral small molecule prodrug that selectively and periodically targets lymphocytes that are integral to the pathological process of MS.
The product is currently under clinical investigation and not yet approved for use in the US, Canada and Europe.
Merck biopharma business global research and development (R&D) head Luciano Rossetti said: “Our submission of the Marketing Authorisation Application for Cladribine Tablets demonstrates Merck's continued commitment to fighting the devastating disease of multiple sclerosis.
“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 by Merck includes data from three Phase III studies, Clarity, Clarity Extension and Oracle MS, and data from the Phase II Onward study.
The trials revealed that Cladribine Tablets could better reduce relapse rates, risk of disability progression, as well as development of new MS lesions as detected by MRI, when compared to placebo in patients affected with relapsing-remitting MS.
Image: Photomicrograph of a demyelinating MS-Lesion. Photo: courtesy of Marvin 101.
