Mavenclad FDA-approved: Infrequent Oral Tablets for MS Treatment

Mavenclad is an oral medication approved for relapsing-remitting and secondary progressive multiple sclerosis.   The oral treatment course consists of two yearly courses of 2 cycles of 1-2 tablets per day for 4-5 days depending on the patient’s weight.

In the CLARITY study, 1326 multiple sclerosis patients were randomized to a total dose of 3.5 mg/kg (FDA-approved dose), 5.25 mg/kg or placebo.  Mavenclad 3.5 mg/kg total dose reduced relapses by 58% compared to placebo.  Likelihood of progression of disability was reduced by 33% on Mavenclad.  On MRI, Mavenclad reduced contrast-enhancing lesions by 86% and new or enlarging T2 lesions by 73% compared to placebo.

Risks of Mavenclad include low white blood cell counts, serious infections, anemia, potential fetal harm and possible malignancy.  Per prescribing information, use of MAVENCLAD is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate drug indicated for the treatment of MS due to its safety profile.