Key Points

• Mayzent is classified as a sphingosine-1-phosphate (S1P) receptor modulator used for various forms of multiple sclerosis (MS).
• Mayzent attaches to the S1P1 receptor on lymphocytes (white blood cells) and helps to keep them from entering the central nervous system (CNS) of patients with multiple sclerosis. It is thought this helps to lower inflammation.
• Mayzent will not cure MS, but it can help to decrease the frequency of relapse symptoms. In Phase 3 studies, Mayzent was shown to significantly slow down ongoing disability in people with active secondary progressive disease (SPMS with relapses).

How does Mayzent work in MS?

Mayzent (siponimod) works in your central nervous system (brain and spinal cord). How Mayzent exerts therapeutic effects in multiple sclerosis is not fully known, but may involve reduction of lymphocyte (white blood cell) migration into the central nervous system (CNS). By blocking the movement of lymphocytes in the CNS, inflammation may be reduced in MS patients.

Mayzent will not cure MS, but it can help to decrease the frequency of relapse symptoms. According to animal research, it may have an effect where MS is active and nerve damage is occurring. Mayzent is used only if you have a specific genotype (CYP2C9 genetic type). Your doctor will test you for this genetic type of MS. Do not use Mayzent if you have a CYP2C9*3/*3 genotype.

Mayzent, from Novartis, is approved for relapsing forms of multiple sclerosis, which include clinically isolated syndrome, relapsing-remitting disease (RRMS) and active secondary progressive disease (SPMS with relapses). Mayzent is classified as a sphingosine-1-phosphate (S1P) receptor modulator.

Clinical studies for Mayzent

In the pivotal Phase 3 EXPAND study, a placebo-controlled clinical trial of 1,651 patients with SPMS, Mayzent significantly lowered disease progression at 3 months by 21%, as well as the number of relapses and physical and cognitive decline. Nearly 3 out of 4 people taking Mayzent showed no confirmed disability progression compared to a placebo (74%, compared to 68% taking placebo).

Other results from this study:

• In patients with non-active SPMS (SPMS without relapses), the results were not statistically significant.
• No significant difference was found when looking at Mayzent compared to placebo in the timed 25-foot walk test (a test that measures the average of how quickly someone can walk 25 feet).
• Those taking Mayzent reduced their annual relapse rate (ARR) by 55% when compared to those taking placebo. ARR is the average number of relapses someone has in 1 year.

The trial continued for over 3 years, and patients stayed in it for close to 2 years (21 months, a median value). The length of time patients stayed in the study ranged from 1 day to 37 months.

Patient Attributes: Phase 3 EXPAND Study With 1651 Patients

*Clinical trial included people with active and non-active SPMS

Mayzent Side Effects

The most common side effects in patients receiving Mayzent include:

• headache
• high blood pressure
• elevations in certain liver function tests

Serious side effects of Mayzent can include:

• slowed heart rate (bradycardia)
• infections
• macular edema, a build-up of fluid in the eyes that may affect your vision

If you have certain heart 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. An electrocardiogram (ECG), a test that measures the electrical activity of your heartbeat, should be conducted at the end of this observation period.

This is not a full list of side effects or warnings. Talk to your doctor to understand important information related to the safety of Mayzent.

Approval of Mayzent

Mayzent was approved in March 2019 as the first oral treatment for active secondary progressive multiple sclerosis (SPMS). It is also approved to treat other relapsing forms of MS, including clinically isolated syndrome (CIS) and relapsing remitting disease (RRMS) in adults.

Mayzent is taken once a day, with or without food, as a maintenance dose after an initial titration period.

What is active secondary progressive multiple sclerosis (SPMS)?

Most people with MS (85%) have RRMS, where the immune system attacks healthy tissue. Active SPMS is the early stage of SPMS that follows the relapsing-remitting MS (RRMS) stage. Roughly 80% of patients with RRMS eventually transition to SPMS.

In general, 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. Patients may eventually lose both physical functioning, such as walking, and thinking and memory (cognitive) skills.

In adults, there are three main types of MS:

• relapsing-remitting MS (RRMS)
• secondary progressive MS (SPMS)
• primary progressive MS (PPMS).

In SPMS:

• Your disability is steadily increasing but you have fewer relapses.
• Active lesions appearing on your MRI may decrease, but your symptoms may still be getting worse.
• Your MS symptoms are lasting longer between relapses.

Bottom Line

• Mayzent works in your central nervous system (brain and spinal cord) and is thought to block the movement of lymphocytes (white blood cells) in the CNS, lowering inflammation and possible nerve damage in MS patients.
• Phase 3 clinical trials, Mayzent significantly lowered disease progression in people with SPMS by 21% at 3 months.
• Mayzent was approved in March 2019 as the first oral treatment for active secondary progressive multiple sclerosis (SPMS). It is also approved to treat other relapsing forms of MS.

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.