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FDA approved 2 new multiple sclerosis drugs. Here's what you should know about them.
FDA approved cladribine (Mavenclad) tablets to treat relapsing forms of multiple sclerosis (MS) in adults, to include relapsing-remitting disease (RRMS) and active secondary progressive multiple sclerosis (SPMS). A second oral drug, siponimod (Mayzent), has been approved to treat adults with relapsing forms of multiple sclerosis, including SPMS with active disease, RRMS, and clinically isolated syndrome (CIS).
Novartis’ Mayzent is expected to carry a wholesale acquisition cost of $88,500 annually-approximately 7% less than Gilenya, the pharma maker’s current major MS treatment.
Mayzent will be available in early April, Novartis said in a statement.
"We are grateful that there is a new treatment option for adults with active secondary progressive MS," said Bruce Bebo, PhD, executive vice president of Research with the US National MS Society, in the Novartis statement. “We are hopeful this approval will stimulate a conversation between patients and healthcare professionals about disability progression after relapsing remitting MS and its early management.”
The efficacy of Mayzent was shown in a clinical trial of 1,651 patients that compared Mayzent to placebo in patients with SPMS who had evidence of disability progression in the prior 2 years and no relapses in the 3 months prior to enrollment.
The fraction of patients with confirmed progression of disability was statistically significantly lower in the Mayzent group than in the placebo group, FDA said. Mayzent also decreased the number of relapses experienced by these patients. In the subgroup of patients with non-active SPMS, the results were not statistically significant.
Mavenclad from EMD Serono was cleared by FDA in late March.
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. In addition, the drug is not recommended for MS patients with clinically isolated syndrome.
“The approval of Mavenclad represents an additional option for patients who have tried another treatment without success,” said Billy Dunn, MD, director of the Division of Neurology Products in FDA’s Center for Drug Evaluation and Research, in a statement from the agency.
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,” FDA said.