The FDA-approved medications offer additional treatment options for people living with active secondary progressive multiple sclerosis (SPMS).


Until the last few months, the vast majority of treatments for multiple sclerosis (MS) were approved to treat the relapsing form of the disease.  Two new disease-modifying therapies — siponimod (Mayzent, Novartis) and cladribine (Mavenclad, EMD Serono) — were approved by the U.S. Food and Drug Administration (FDA) for use in active secondary progressive multiple sclerosis (SPMS).

Multiple sclerosis can have a profound impact on a person’s life,” said Billy Dunn, M.D., director of the Division of Neurology Products in the FDA’s Center for Drug Evaluation and Research, in the press release from the FDA announcing the approval of siponimod.  “We are committed to continuing to work with companies that are developing additional treatment options for patients with multiple sclerosis.”

In the FDA’s announcement of the approval of the use of cladribine in these cases, Dr. Dunn said that the government agency is “committed to supporting the development of safe and effective treatments for patients with multiple sclerosis.”

“The approval of Mavenclad represents an additional option for patients who have tried another treatment without success.”

MAYZENT (siponimod) is a pill that is used to treat relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
In secondary progressive MS, siponimod reduced risk of disability progression by 21% compared to placebo.  In a phase II study (BOLD), designed to assess the best dose for reducing MS activity as seen on MRI scans, 188 people with relapsing remitting MS took siponimod for 3 to 6 months. Siponimod reduced the number of brain lesions seen in MRI by up to 80% and reduced relapse rates compared to placebo (0.58 on placebo to 0.2 on 2 mg siponimod).
MAVENCLAD is a short-course oral treatment

You take Mavenclad as a pill in two treatment courses, twelve months apart.  In clinical trials, people taking Mavenclad had about 50% fewer relapses than people taking placebo. In clinical trials, MRI scans showed that people taking Mavenclad had fewer, smaller or no new areas of active MS (lesions). Mavenclad may also slow down the build-up of disability due to MS.

CLARITY was a two year, phase III study in more than 1,300 people comparing two doses of Mavenclad against placebo. Compared to placebo, there was a reduction in the relapse rate of 58%. Later analyses of the study results also found that brain volume loss was reduced and numbers of participants with no evidence of disease progression (NEDA) were increased in those taking Mavenclad.​


What is SPMS?

Secondary Progressive MS follows an initial relapsing-remitting course. Most people who are diagnosed with RRMS will eventually transition to a secondary progressive course in which there is a progressive worsening of neurologic function (accumulation of disability) over time. SPMS can be further characterized at different points in time as either active (with relapses and/or evidence of new MRI activity) or not active, as well as with progression (evidence of disease worsening on an objective measure of change over time, with or without relapses) or without progression.

In the past, before DMTs came along, it usually took around 20 years for relapsing MS (RRMS) to change into secondary progressive MS (SPMS). But thanks to today’s MS drugs this is changing:

  • fewer people are likely to go on to secondary progressive MS
  • for those that do, this could take longer to happen

Secondary progressive MS can be hard to diagnose. Before a neurologist will tell you that you’ve got this kind of MS, they’ll look for signs that your MS has been getting steadily worse for six months.

It’s possible that, when you’re first diagnosed with MS, you could be told you have secondary progressive MS. This is rare but can happen if symptoms of the relapsing remitting phase of your MS weren’t diagnosed correctly or were ignored.

Secondary progressive MS is different from primary progressive MS, which is progressive from the beginning.