Medicine & Research

New Treatment Options Approved
 
The new oral treatments were approved for use in March of 2019. The U.S. Food and Drug Administration approved Novartis’ Mayzent® (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. The FDA also approved EMD Serono’s Mavenclad® (cladribine) to treat relapsing forms of MS, including relapsing remitting MS and active secondary progressive MS.
 
Mayzent
Dosing: Mayzent is a daily oral medication.
The Research:
            It was shown to be effective in a clinical trial of 1,651 patients. The trial compared Mayzent to placebo in patients with secondary progressive MS who had evidence of disability progression in the prior two years and no relapses in the three months prior to enrollment. The primary endpoint of the study was the time to three-month confirmed progression in disability. The fraction of patients with confirmed progression of disability was statistically significantly lower in the Mayzent group than in the placebo group. Mayzent also decreased the number of relapses experienced by these patients.
The Warnings:
            Mayzent may increase the risk of infections, so patients should have a complete blood count taken before treatment is initiated. The drug may cause macular edema, so patients should contact their physician if they experience a change in vision. Mayzent may cause transient decreases in heart rate and may cause a decline in lung function. Liver enzymes should be checked before initiation of the drug and healthcare professionals should closely monitor patients with severe liver impairment. Healthcare professionals should monitor the patient’s blood pressure during treatment. Women of childbearing potential should use effective contraception during and for 10 days after stopping the drug because of the potential risk of fetal harm.
            For more information on Mayzent, and prescribing information, visit www.mayzent.com
 
Mavenclad
Dosing: Mavenclad is an oral medication with a maximum of 20 days of treatment over a two-year period (no more than ten days per year). Following treatment over those two years, additional courses are not to be administered. Re-treatment with Mavenclad during years three and four may further increase the risk of malignancy. The safety and efficacy of reinitiating Mavenclad more than two years after completing two treatment courses has not been studied.
The Research:
            The efficacy of Mavenclad was shown in a clinical trial in 1,326 patients with relapsing forms of MS who had least one relapse in the previous 12 months. Mavenclad significantly decreased the number of relapses experienced by these patients compared to placebo. Mavenclad also reduced the progression of disability compared to placebo.
The Warnings:
            Mavenclad is not recommended for MS patients with clinically isolated syndrome. Because of its safety profile, the 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. Mavenclad has a boxed warning for an increased risk of malignancy and fetal harm. Mavenclad is not to be used in patients with current malignancy. The drug should not be used in pregnant women and in women and men of reproductive potential who do not plan to use effective contraception during treatment and for six months after the course of therapy because of the potential for fetal harm. Mavenclad should be stopped if the patient becomes pregnant.
            Other warnings include the risk of decreased lymphocyte (white blood cell) counts; lymphocyte counts should be monitored before, during, and after treatment. Mavenclad may increase the risk of infections; healthcare professionals should screen patients for infections and treatment with Mavenclad should be delayed if necessary. Mavenclad may cause hematologic toxicity and bone marrow suppression so healthcare professionals should measure a patient’s complete blood counts before, during, and after therapy. The drug has been associated with graft-versus-host-disease following blood transfusions with nonirradiated blood. Mavenclad may cause liver injury and treatment should be interrupted or discontinued, as appropriate, if clinically significant liver injury is suspected.
            For more information on Mavenclad, and prescribing information including the boxed warnings, visit www.mavenclad.com.