Mavenclad (cladribine) tablets stand out as a treatment for relapsing forms of multiple sclerosis (MS), providing two years of proven efficacy with a maximum of 20 days of oral treatment, a top executive with EMD Serono says.
After being approved in more than 50 countries worldwide, including the European Union, Australia, and Canada, Mavenclad is now also available in the U.S., following its March 29 approval by the U.S. Food and Drug Administration (FDA) for relapsing-remitting (RRMS) and active secondary progressive disease (SPMS).
These U.S. indications are less restrictive than in Europe, where Mavenclad is only indicated to treat highly active relapsing forms of MS.
“We’re really excited about the FDA approval,” John Walsh, MD, EMD Serono’s vice president of neurology and immunology, U.S. medical affairs, and interim head of North America medical affairs, said in an interview with Multiple Sclerosis News Today. “This is a great time not only for EMD Serono but most importantly for patients, and we’re really, really proud to offer this therapy because it’s the only short-course oral treatment where physicians can treat patients with RRMS as well active SPMS.”
Mavenclad is given in two treatment courses of two weeks each, separated by approximately one year. In each course, the patient receives eight to 10 tablets, for a maximum of 20 tablets over two years. The exact number of tablets a patient receives depends on his/her body weight, with a targeted cumulative dose of 3.5 milligrams per kilogram.
Due to its safety profile, Mavenclad is recommended for patients who failed to respond or were unable to tolerate other MS treatments.
“We really believe that making sure that patients and prescribers have options that fit the needs of different patients is important, and we think that Mavenclad certainly can offer options to people who may be looking for different therapies,” Walsh said.
Different measures supporting efficacy
The safety and efficacy of Mavenclad were evaluated in Phase 2 and 3 trials in more than 2,700 relapsing MS patients, some of whom were followed for more than 10 years.
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