Key Points

• Mayzent (siponimod) is an oral, maintenance (long-term) medication to treat active secondary progressive multiple sclerosis (SPMS) and other relapsing forms of MS. You would take this medication as long as you are having a positive effect and are tolerating the medication.
• Mayzent is a tablet taken once a day, with or without food, after an initial titration period. It’s important to take your medication as prescribed because if you stop treatment you may have to restart the titration period or retake blood tests.
• In Phase III clinical trials, Mayzent significantly lowered disease progression in people with SPMS by 21% at 3 months. In 3-year studies, the length of time patients stayed in the study was variable. For individual patients, median study duration was 21 months, but this ranged from 1 day to 37 months.

Mayzent, from Novartis, was approved in March 2019 as the first oral treatment for active secondary progressive multiple sclerosis (SPMS). It is also used to treat other relapsing forms of MS, including clinically isolated syndrome (CIS) and relapsing remitting disease (RRMS) in adults. Mayzent is an oral tablet taken once daily on a maintenance basis (meaning over the long-term).

It is important you take your medicine every day unless your doctor tells you otherwise. If your treatment is stopped for 4 or more days in a row, you must restart Mayzent with the 4- or 5-day titration schedule. If you stop during the initial titration period, you may need to retake blood tests.

Understanding secondary progressive multiple sclerosis (SPMS)

Multiple sclerosis (MS) is a long-term inflammatory disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves (eyes) and spinal cord.

In MS, the immune system attacks healthy tissue like the nerve covering (myelin sheath) that wraps around and protects each nerve. Without this protective covering, inflammation occurs on the nerve leading to scar tissue (this is known as sclerosis).

Sclerosis affects how nerve signals work in the body. Patients may eventually lose physical ability, such as balance and walking, as well as cognitive skills like adequate thinking and memory.

There are three main types of MS:

• Relapsing-remitting MS (RRMS)
• Secondary progressive MS (SPMS)
• Primary progressive MS (PPMS)

About 85% of people with MS have RRMS, the most common form. Active Secondary Progressive MS (SPMS) is the stage that comes 10 to 15 years after your RRMS diagnosis and disability steadily gets worse. Roughly 80% of patients with RRMS eventually transition into SPMS.

In SPMS your disability steadily increases but you have fewer relapses and remissions. Active CNS lesions that appear on your MRI imaging study may decrease, but your symptoms may still be worsening. Your MS symptoms tend to last longer between relapses or you may experience new symptoms.

How do I know if I have SPMS?

Only your doctor can diagnose your transition to SPMS. You may see these changes that persist in between relapses, such as:

• difficulty with balance
• trouble walking
• bowel and bladder problems
• poor memory and difficulty concentrating
• numbness or tingling in your arms or legs
• fatigue and tiredness
• pain
• vision and eye problems (blurred vision)
• muscle spasms and weakness
• difficulty speaking or swallowing

Your symptoms of active SPMS may be different from someone else, so be sure to talk to your doctor about how you feel.

How Mayzent works

Mayzent is classified as a sphingosine-1-phosphate (S1P) receptor modulator. Mayzent attaches to the S1P1 receptor on lymphocytes (white blood cells).

Mayzent appears to work in MS by reducing the movement of white blood cells (called lymphocytes) into the CNS (brain and spinal cord). This can help to lower inflammation that leads to pain and swelling in the nerves, and may help limit damage. How Mayzent fully works in MS is not known.

Mayzent is used only if you have a specific CYP2C9 genotype. Your doctor will test you for this genotype.

Mayzent will not cure MS, but may decrease the frequency of your relapse symptoms.

How long did patients stay on Mayzent in studies?

In the pivotal Phase 3 EXPAND study, a placebo-controlled clinical trial of over 1,650 patients with SPMS, Mayzent significantly lowered patient’s disease progression by 21% at 3 months.

• The number of relapses and physical and cognitive decline was also reduced.
• Nearly 3 out of 4 people taking Mayzent showed no confirmed disability progression compared to a placebo (74%, compared to 68% taking placebo).
• The trial continued for over 3 years, and patients remained in the trial for close to 2 years (median time). However, the length of time patients stayed in the study ranged from 1 day to 37 months.

What side effects are most common with Mayzent?

The most common side effects in patients receiving Mayzent include headache, high blood pressure and elevations in liver function lab tests.

If you have certain heart (cardiovascular) risk factors, for example a history of heart attacks or heart failure, you may need to be monitored for a period of 6 hours after taking your first dose of Mayzent. This is known as the First Dose Observation period. Mayzent can cause your heart rate to slow down during the first dose, so you might need to be monitored by your doctor. Most patients won’t need a first dose observation.

An electrocardiogram (ECG), a test that measures the electrical activity of your heart, should be done at the end of this first dose observation period.

Bottom Line

• Mayzent is meant to be taken as a long-term (maintenance) medication for various forms of MS. How long you stay on Mayzent will depend upon your response to the medication and if you are tolerating any side effects.
• Phase III pivotal research with Mayzent continued for over 3 years. Patients stayed in the trial for a median time of 21 months that ranged from 1 day to 37 months. Your results may not be the same as other patients taking Mayzent.
• It is important you continue your medicine every day as prescribed, unless your doctor tells you to stop.
  • If you miss 1 or more doses during the initial titration period, you'll need to restart the medication and retake the blood tests.
  • If your treatment is discontinued for 4 or more days in a row, you must restart Mayzent with the 4- or 5-day titration schedule.

This is not all the important information you need to know about Mayzent effectiveness and safety. Speak with your health care provider about this medication and review the full prescribing and patient information here.