Merck KGaA, Darmstadt, Germany, a leading science and technology company, today announced that MAVENCLAD® (cladribine tablets) has been approved for the treatment of highly active relapsing remitting multiple sclerosis* (RRMS)i in Switzerland. Cladribine tablets is the only treatment for RRMS that provides the possibility of up to four years of disease control with a maximum of 20 days of oral treatment administered over two years.

"The Swissmedic approval of Cladribine tablets is great news for patients in Switzerland with highly active relapsing remitting MS," said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. "These patients have had limited treatment options and Cladribine tablets, now approved in 52 countries worldwide, represents an important new therapy with a novel mechanism as the first short-course oral treatment for relapsing remitting MS in Switzerland."

Cladribine tablets has demonstrated durable clinical efficacy for up to four years across key measures of disease activity, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity. The approval of cladribine tablets is based on more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of observation in some patients. The clinical development program included data from three placebo-controlled Phase III trials, CLARITY (pivotal efficacy study)ii,iii CLARITY EXTENSIONiv and ORACLE MS,v the Phase II ONWARD study;vi and long-term follow-up data from the 8-year prospective registry, PREMIERE.vii The efficacy and safety results of these studies allowed for a full characterization of the benefit-to-risk profile of cladribine tablets.

"To receive a reliably effective therapy remains the most important consideration for patients," said Professor Ludwig Kappos, Chair Neurology, University Hospital Basel, Switzerland. "The medium and long-term treatment risks ought to be as low as possible. Last but not least the treatment should be very compatible with a normal daily life. The approval of cladribine tablets for highly active relapsing remitting multiple sclerosis by Swissmedic in Switzerland is good news because it extends the range of options for this group of MS patients with an oral treatment with proven, long-lasting effect."

In patients with high disease activity, post hoc analyses of the two-year Phase III CLARITY trialii,viii demonstrated that cladribine tablets reduced the annualized relapse rate by 67% and the risk of 6-month confirmed Expanded Disability Status Scale (EDSS) progression by 82% versus placebo. As demonstrated in the Phase III CLARITY EXTix study, no further cladribine tablets treatment was required in Years 3 and 4. Cladribine tablets has a well-characterized safety profile, with up to ten years of observation in some patients and no reported cases of progressive multifocal leukoencephalopathy (PML)† in MS. The most clinically relevant adverse reactions were lymphopenia and herpes zoster. Lymphocyte counts must be assessed before, and during, treatment with Cladribine tablets. Cladribine tablets is contraindicated in certain groups including immunocompromised patients and pregnant women.

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