Earlier this year, the FDA granted approval of Mayzent (siponimod) to Novartis for relapsing multiple sclerosis (MS). As of November 2019, Novartis has received positive feedback.
Individuals take Mayzent in tablet form once a day; it is the first treatment for people who have active secondary progressive multiple sclerosis (SPMS) in more than 15 years. Mavenclad (cladribine) was also approved for relapsing-remitting multiple sclerosis (RRMS).
Around 1 million people in the United States are currently living with MS and 2.3 million worldwide. MS is an autoimmune disorder that targets the central nervous system. It is one of the most common neurological disabilities in young adults and shows up more in women. Symptoms tend to arise in individuals aged between 20-40 and occurs by disrupting the communication between the brain and other parts of the body.
Individuals with RRMS have a 50 percent chance of progressing to SPMS within the first decade of diagnosis. After 25 years, 90 percent of individuals have a chance of progressing.
How Mayzent Works
Mayzent targets the white blood cells found in lymph nodes, which play a significant role in the inflammatory responses of MS. By targeting these white blood cells, the drug helps to prevent over inflammation. Through pathways that researchers are still exploring, the medicine then slows progression in advanced stages.
During clinical trials, out of 1,651 patients suffering from SPMS, there was a lower number with disease progression in the Mayzent group. The reduction for annualized relapse rate was around 55 percent.
Mayzent is significant because it works in the brain. MS is destructive because it enters the immune system and then attacks the brain and causes problems. Mayzent starts working in the brain before doing anything else.
As far as risks and side effects, Mayzent comes with a patient Medication Guide that describes essential information.
The drug can increase the risk of:
- Infections, so patients must have their blood cell counts taken prior to treatment
- Developing macular edema
- Temporary heart rate decreases
- A decline in lung function
- Liver impairment, so doctors must check liver enzymes prior to treatment, especially in those with compromised livers
- Fetal harm, therefore women who are trying to get pregnant cannot take attempt to conceive prior to ten days after treatment
Common side effects of taking Mayzent include headache and high blood pressure.
The last concern requires navigation through different insurance coverage. Mayzent comes with a hefty price tag – $88,500 for the treatment.
How Mavenclad for Relapsing Multiple Sclerosis Works
Mavenclad works similarly to Mayzent in that it targets lymphocytes which cause over inflammation during MS. Attack of these lymphocytes help fight over inflammation without compromising the rest of the immune system.
During clinical trials, 1,976 patients who experienced relapsing forms of MS within the past year, were eligible for the study. Patients who took Mavenclad had a significant decrease in relapses as well as slower progression of disability. The reduction for annualized relapse rate was 58 percent and for disability progression, 33 percent.
Patients on Mavenclad also had a lower number of lesions.
There is quite a safety profile on this drug. So it’s imperative that patients and their families discuss the risks versus benefits prior to initialization of treatment. For patients who cannot tolerate or are unresponsive to alternate regimens, Mavanclad may be an optimal route.
Taking Mavenclad increases the risk of:
- Decreased white blood cell counts and therefore increased risk of infections
- Liver injury
- Fetal harm and therefore women should avoid attempts at pregnancy for six months after treatment ends
Also, patients suffering from a form of MS known as clinically isolated syndrome, are not eligible for Mavenclad.
As far as the regimen, patients take the drug over the course of 8 to 10 days, two years in a row.
Common side effects of Mavenclad include upper respiratory tract infections and headaches, herpes, and alopecia (hair loss). Novartis has estimated Mavenclad to cost $99,500 for the two-year treatment, so availability for treatment is coming slowly.
For more information on MS, visit https://www.nationalmssociety.org/What-is-MS.