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FDA Approves New Oral Treatment for MS

On March 26th, 2019, the United States Food and Drug Administration (FDA) announced that it has approved a new oral medication to treat adults with relapsing forms of multiple sclerosis (MS). The medication, Mayzent (siponimod), is approved to treat clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease forms of MS.

The FDA recognizes that MS can have a profound impact on a patient’s life and that there is a need for innovative therapy. The FDA reinforced its commitment to working with companies that are developing new and better therapies for MS treatment.

Trials

MS tends to be a disease that has incidents of worsening symptoms (relapses), which are followed by periods of symptom lessening (remissions). Some patients do not experience full remissions, and continue to have some form of disability. Other patients may continue to experience worsening of their symptoms even throughout their relapse and remission cycles, in a process known as secondary progressive multiple sclerosis (SPMS).

A clinical trial studied Mayzent versus a placebo medication in 1,651 patients with SPMS who had shown signs of disability or disease progression in the past two years, but had not had a relapse in at least 3 months prior to starting the trial. Patients on Mayzent were significantly less likely to have a confirmed three-month progression than patients on the placebo. These patients also had a decreased number of SPMS relapses.

Side effects

Like all medications, Mayzent is not without side effects. The most common symptoms experienced by multiple sclerosis patients are:

  • Headache
  • Increased blood pressure
  • Liver function test increases

You doctor should check your liver functions before you start Mayzent, and should monitor both your liver functions and your blood pressure regularly while you take this medication. Mayzent can increase your risk of getting an infection, so your doctor should run a complete blood count (CBC) and monitor your CBC as you are being treated. If you notice any vision changes while you are taking Mayzent, let your physician know right away, as Mayzent has been associated with macular edema. Your physician should monitor you for posterior reversible encephalopathy syndrome while you take Mayzent.

Mayzent may cause your heart rate to drop (also known as bradychardia), and can cause a decrease in lung function, so talk to your physician about any respiratory issues you may have before starting Mayzent. You should talk to your doctor about any immunosuppressant or immune modulating therapies that you are taking, as Mayzent may unintentionally lower your immune system. Women who can become pregnant should use an effective form of birth control while taking Mayzent, and for 10 days after stopping the medication.

Another step forward

Mayzent is a step forward in providing treatment options for patients with multiple relapsing forms of MS and paves the way to make new therapies available for patients who have limited medication choices.

  1. FDA approves new oral drug to treat multiple sclerosis. Fda.gov. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm634469.htm. Published 2019. Accessed March 27, 2019.

Comments

  • Anonymouse
    2 months ago

    While it is good to see new treatment options, the list of risks patients are taking on with this new medication is as usual quite dismaying.

    I am currently using Avonex, and (speaking only for myself) it’s a harsh regimen. This is especially true given that many of us are treating without knowing at all what our disease course would be otherwise.

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