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Cladribine Tablets Are Only a Step Away from European Approval

June 29, 2017

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended that the European Commission approve Merck’s cladribine tablets for relapsing multiple sclerosis. However, Cladribine, or trade name Mavenclad, is still going through clinical trials in the United States and Canada. The European Commission is expected to make a final decision on the application within 67 days of receiving the European Medicine Agency recommendation.

Three Phrase 3 clinical trials have shown cladribine tablets to be safe and effective against relapse-remitting MS (RRMS). The trials have yielded information about cladribine dose levels, monitoring requirements, and side effects. The CLARITY trial demonstrated how cladribine reduced the annual relapse rate of RRMS patients by 67%. The treatment also significantly reduced the risk of a patient’s disability worsening after 6 months, compared with a placebo. The CLARITY EXTENSION trial demonstrated cladribine’s long-term ability to control the disease.

“We strongly believe in the therapeutic value of cladribine tablets and the significant impact this investigational therapy may have on the future of MS care,” said Luciano Rossetti, the head of Merck’s biopharma business research and development arm.