The FDA has just announced that they’ve approved Mayzent for the treatment of relapsing multiple sclerosis (MS).
Multiple Sclerosis
Multiple sclerosis is a neurological autoimmune disease. It causes a wide array of symptoms ranging from optic neuritis, to dysarthria, to paraesthesias, to cognitive impairment and many more. MS is usually diagnosed between the ages of 20 and 40 and it tends to be more common among women. Most patients experience periods of remission and relapse as opposed to constant symptoms. However, even in periods of relapse, residual disability is often present.
Some patients experience secondary progressive MS or SPMS. This means they experience progressive disability independent of relapses. Active SPMS refers to the beginning stages of SPMS where relapses still occur.
Mayzent
Mayzent has been approved for adult MS patients who have a relapsing form of the condition. Relapsing forms of MS include active SPMS, relapse-remitting disease, and clinically isolated syndrome.
The trial which supported Mayzent’s approval included 1,651 SPMS patients who came from 31 different countries. Some of these patients had active SPMS and some had non-active SPMS. All of the participants had disability progression in the two years before they enrolled in the trial and had not experienced relapses in the last three months before they began the trial. The study examined the time to three-month confirmed disability progression. This progression was much lower in those treated with Mayzent. This group of patients also experienced fewer relapses.
The group of non-active SPMS participants in this trial were not found to have statistically significant results from treatment with Mayzent.
Mayzent may cause side effects such as macular edema, immunosuppression, and posterior reversible encephalopathy syndrome so patients taking the drug should be monitored closely. However, in the clinical trial supporting its approval the most common AEs were high blood pressure, headache, and liver damage.
This approval is extremely exciting for this patient community as Mayzent has great potential to improve the quality of life of those living with relapsing MS.
You can read more about Mayzent and the trial that led to its approval here.
