Zeposia, a new drug for BSM multiple sclerosis, has been approved by the European Union

May 27th, BMS announced that the European Commission (EC) had approved Zeposia (ozanimod) for the treatment of adult patients with active relapsed relapsed multiple sclerosis (RRMS) defined by clinical or imaging characteristics.Zeposia is an oral selective arginol 1-phosphate (S1P) subject regulator that selectively binds to S1P subtypes 1 (S1P1) and 5 (S1P5) with high affinity. In March, Zeposia received FDA approval to treat adult multiple sclerosis, including clinical isolation syndrome, relapsed remission-relieving multiple sclerosis, and active secondary progressive multiple sclerosis.Fda and EC approvals are based on the largest, head-to-head critical Phase 3 clinical trials conducted so far in MS patients, SUNBEAM and RADIANCE Part B. The two studies involved more than 2,600 patients in 150 regions in more than 20 countries around the world. Key findings include:Zeposia reduced ARR by 48% in a year in the SUNBEAM study (ARR: 0.18 vs. 0.35); In the study, AAR was reduced by 38% over two years (AAR: 0.17 vs. 0.28);in the SUNBEAM study, the treatment was one year, compared to Avonex, Zepo Sia reduced the number of T1 weighted palaeum enhancement (GdE) brain injuries by 63% (0.16 vs 0.43) and the number of new or expanded T2 injuries by 48% (1. 47 vs 2.84);In the ANNUAL STUDY, Zeposia reduced the number of T1-weighted GdE brain injuries by 53% compared to Avonex in the two-year study (0.18 vs. 0.37), a relative reduction of 42% (1.84 vs. 3.18) in the number of new or expanded T2 injuries.Zeposia reduces total brain volume from baseline by a greater margin than Avonex (SUNBEAM Study: -0.41% vs .61%, RADIANCE Study: -0.71% vs .94%).Dr Samit Hirawat, Chief Medical Officer, BMS, said: "Phase 3 clinical trials have shown that Zeposia can significantly improve relapse and brain lesions caused by this catastrophic disease. EC approval provides active RRMS patients with the opportunity to use Zeposia as an option for first-line treatment. Multiple(MS) is a disease caused by the immune system attacking protective myelin that covers nerves, causing damaging lesions and blocking the transmission of nerve cell signals. This "signal failure" can lead to related illnesses and relapses. RRMS is characterized by a well-defined onset of worsening nerve function. For active RRMS patients, Zeposia is the only S1P regulator approved for the condition. (Sina Pharmaceutical News)