U.S. FDA Approves Cladribine for People with Active Secondary Progressive MS

The U.S. Food and Drug Administration has approved oral cladribine (brand named Mavenclad®– EMD Serono) for the treatment of adults with relapsing-remitting MS and active secondary progressive MS, based on clinical trials showing it could decrease the number of relapses and slow the accumulation of physical disability caused by MS, compared to placebo. This approval provides a new treatment option for people living with secondary progressive MS who are continuing to experience active disease.

Cladribine is a treatment that targets certain types of white blood cells (lymphocytes) that drive the immune attack in MS. It temporarily reduces the number of both T and B lymphocytes without continuous suppression of the immune system. Because of its safety profile, Mavenclad is generally recommended in people with MS who have had an inadequate response to, or are unable to tolerate, another MS therapy.

Mavenclad has a boxed warning due to an increased risk of cancers and risk of fetal (unborn baby) harm. Potential safety issues identified by the FDA include decrease in white blood cells, and increased risk of infections and liver injury. The most common adverse reactions reported during clinical trials included upper respiratory tract infections, headache, and low white blood counts. Mavenclad is taken by mouth in two treatment courses, twelve months apart. More information will be provided when the full prescription information and medication guide become available.

“Momentum continues to build with the approval of a third treatment for progressive forms of MS in the United States. Critical progress is being made to address the unmet need of more than one million people living worldwide with progressive MS. While this agent is limited to those with relapses or new disease activity measured by MRI, this and other recent treatment milestones are important and worthy of celebration.”

Prof. Alan Thompson, Chair of the Alliance’s Scientific Steering Committee and Dean of University College London Faculty of Brain Sciences

Mavenclad has been authorized for use in the European Union by the European Medicines Agency (EMA) for relapsing remitting MS, but not for active secondary progressive MS at this time. The EMA is the body responsible for drug licensing in Europe.

The Alliance, a global collaboration of MS organizations, researchers, healthcare professionals, the pharmaceutical industry, companies, trusts, foundations, donors and people affected by MS, continues its vital work to accelerate the discovery of new treatments for all people affected by progressive MS.

About Secondary Progressive MS

Secondary Progressive MS (SPMS) follows an initial relapsing-remitting course. Most people who are diagnosed with Relapsing-Remitting MS will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. Secondary Progressive MS can be further characterized as either active (with relapses and/or evidence of new MRI activity) or not active (no relapses and no evidence of new MRI activity). Mavenclad is approved for active SPMS.

Further information

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