FDA Approves Cladribine (Brand-named Mavenclad®)

The US Food and Drug Administration (FDA) has approved oral cladribine (brand named Mavenclad®, EMD Serono) for the treatment of adults with relapsing forms of MS, including relapsing-remitting MS and active secondary progressive MS. Because of risks and safety profile, 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 targets certain types of lymphocytes (white blood cells) that drive the immune attack in MS. A Phase II clinical trial tested the safety and effectiveness of two different doses of oral Mavenclad in 1,326 people with relapsing-remitting MS compared with placebo. Those taking a lower dose of Mavenclad had a 58% reduction in annual relapse rate compared to people in the placebo group; those taking the higher dose had a 55% reduction compared to placebo.

The prescribing information for Mavenclad includes several warnings and precautions including a boxed warning for increased risk of cancers and birth defects/fetal harm. Other risks include low blood cell counts, infections, liver injury, and heart failure. Click here to read the full Medication Guide.

“This is an older drug that has been repurposed to be used in MS when other therapies have failed,” says Vollmer. “But it is another tool in case we need it in the treatment of MS.”

Additional Resources

FDA’s press release: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634837.htm

Medication Guide:
https://www.emdserono.com/content/dam/web/corporate/non-images/country-specifics/us/pi/mavenclad-mg.pdf