EMA approved Mayzent (siponimod) for secondary progressive multiple sclerosis
Updated: Apr 4
Novartis has announced that it has received the EU approval for Mayzent (siponimod) for adult patients with secondary progressive multiple sclerosis (SPMS). Mayzent is the first and oral treatment explicitly indicated for patients who have secondary progressive multiple sclerosis.
“We are delighted by the news that there is now a treatment available for people in Europe living with active SPMS to potentially delay the progression of this debilitating disease,” said Pedro Carrascal, President of the European MS Platform. He hoped that Mayzent improves the care and quality of life of the patients suffering from SPMS.
The approval was based on the Phase 3 EXPAND trial. EXPAND trial is a randomized, double-blind, placebo-controlled study. The efficacy and safety of the drug compared with placebo. The study included 1,651 people with secondary progressive multiple sclerosis (SPMS). Confirmed disability progression (CDP) risk was reduced by 21% at three months. There was a reduction of T2 lesion volume by 79% compared to the placebo. ARR and Gd-enhancing lesions were the secondary endpoints. ARR is reduced by 55%; 89% of patients were free from Gd-enhancing lesions compared to 67% of patients on placebo.
About secondary progressive multiple sclerosis (SPMS)
SPMS is a form of MS which follows relapsing-remitting multiple sclerosis. In SPMS, the disease progress from relapses to nerve damage or loss. 50% of the patients diagnosed with relapsing-remitting multiple sclerosis progress to SPMS within ten years.
Mayzent earlier received the approval of the US Food and Drug Administration for patients suffering from relapsing multiple sclerosis (RMS), relapsing-remitting multiple sclerosis. The drug received approval for SPMS from the Australian Therapeutic Goods Administration (TGA).