This Treatment for Multiple Sclerosis Could be on its Way to Approval in the EU

According to a story from finanznachricten.de, the drug company Novartis recently announced that the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive review of the medication siponimod (marketed as Mayzent) as a treatment for adult patients with the secondary progressive form of multiple sclerosis (MS) who are dealing with active disease. If approved, Mayzent would be the first-ever orally-administered treatment for patients with this specific indication.

About Multiple Sclerosis

Multiple sclerosis is a neurological disease which is characterized by damage to the myelin sheath, a fatty, insulating, protective covering that surrounds nerve cells and allows them to communicate effectively. Although a precise cause has not been determined, multiple sclerosis is considered an autoimmune disease, in which a certain trigger, such as an infection, may cause the immune system to mistakenly attack healthy tissue. Smoking and certain genetic variants are also considered risk factors for the disease. Symptoms include blurred vision, double vision, blindness in one eye, numbness, abnormal sensations, pain, muscle weakness, muscle spasms, difficulty speaking and swallowing, mood instability, depression, loss of coordination, and fatigue. There are a number of treatments available for the disease, but no cure. Life expectancy for patients is slightly reduced. To learn more about multiple sclerosis, click here.

The most common variant of the disease is called relapsing-remitting multiple sclerosis. The vast majority of therapies for the disease are intended to treat this form. The secondary-progressive form of the illness represents a more advanced stage. Researchers project that as many as 80 percent of patients with the relapsing-remitting variant will eventually progress to the secondary-progressive variant. When the disease has reached this stage, a patient’s options for treatment become much more limited.

Encouraging Findings

The recommendation from CHMP follows promising results from a phase 3 clinical trial. In this study, Mayzent was found to be capable of reducing the risk of progression by 31 percent at three months and 37 percent a six months when compared to placebo. The drug was able to produce favorable changes to brain volume loss, disease activity detected on MRI, and yearly relapse rate, which dropped by 46 percent.

It appears the Mayzent will soon be approved in the EU and it has already been cleared for use in both Australia and the US.

 


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