The U.S. Food and Drug Administration (FDA) has approved Mavenclad (cladribine) tablets for the treatment of adults with relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS (RRMS) and active secondary progressive disease (SPMS).
Up to 85 percent of people with MS are initially diagnosed with relapsing forms of the disease, in which disease flare-ups (relapses) are followed by recovery periods (remissions). In some cases, these recovery periods are incomplete, and as a result, patients may still experience residual disabilities. Over time, most patients progress to a stage of the disease characterized by a gradual worsening of their symptoms that may be accompanied by recurrent relapses; this stage is known as active SPMS.
Mavenclad is a therapy developed and marketed by EMD Serono (known as Merck KGaA outside the U.S. and Canada) that works by reducing the number of immune cells in the patient’s bloodstream that are the cause of nerve degeneration in MS. Due to its safety profile, Mavenclad is normally recommended for patients who failed to respond or were unable to tolerate other treatments for MS.
“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis,” Billy Dunn, MD, director of the division of neurology products in the FDA’s Center for Drug Evaluation and Research, said in an FDA press release. “The approval of Mavenclad represents an additional option for patients who have tried another treatment without success.”
Mavenclad’s approval was supported by findings from a clinical trial program involving a total of 1,976 MS patients who were followed for a maximum of eight years.
Pooled data from the studies showed that more than half of the patients (58%) treated with Mavenclad had a significant reduction in the annualized relapsed rate, compared with those on a placebo (0.14 vs 0.33).
In addition, results showed that more than three-quarters (81%) of the patients who received Mavenclad remained free of relapses over the following two years, compared with 63% of those on a placebo.
Mavenclad-treated patients were also less likely to develop new brain lesions or aggravate existing ones, and experience disability progression than placebo-treated patients.
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