FDA

FDA Approves Another New MS Treatment

Amanda Balbi

The US Food and Drug Administration has approved another new oral treatment for adults with relapsing forms of multiple sclerosis (MS), called Mavenclad (cladribine) tablets.

In a clinical trial of 1326 patients with relapsing MS, Mavenclad significantly decreased the instances of relapse over 12 months compared with placebo.

The most common adverse reactions reported were upper respiratory tract infection, headache, and decreased lymphocyte counts.

“We are committed to supporting the development of safe and effective treatments for patients with multiple sclerosis,” said Billy Dunn, MD, director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research. “The approval of Mavenclad represents an additional option for patients who have tried another treatment without success.”

—Amanda Balbi

Reference:

FDA approves new oral treatment for multiple sclerosis [press release]. Silver Spring, MD: US Food and Drug Administration; March 29, 2019. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634469.htm. Accessed April 1, 2019.