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BMS' Zeposia becomes first S1P receptor modulator available in Europe for relapsing remitting multiple sclerosis

Published on 28/05/20 at 12:22pm

Bristol Myers Squibb is celebrating after its oral therapy Zeposia (ozanimod), secured European Commission for the treatment of relapsing remitting multiple sclerosis in adults with active disease “as defined by clinical or imaging features”, making it the only approved sphingosine-1-phosphate (S1P) receptor modulator in this indication.

Two clinical trials generating data in support of the approval from 2,600 participants across 150 sites internationally revealed that Zeposia reduced the rate of annualised relapse by 48% compared to Biogen’s injectable Avonex (interferon beta-1a) after one year of treatment, and by 38% at two years.

Zeposia also reduced the number of T1‑weighted gadolinium-enhanced (GdE) brain lesions in patients by 63% and new or enlarging T2 brain lesions by 48% after one year. After two years,  a relative reduction of 53% and 42% was seen, respectively. Whole brain volume was also reduced by a greater percentage from baseline with Zeposia compared to Avonex over two years of treatment.

“There is no one-size-fits-all approach to treating MS. Patients respond differently to currently available therapies, which is why having options that address the hallmark characteristics of RRMS is so important,” commented Dr Giancarlo Comi, Honorary Professor of Neurology, Director of the Institute of Experimental Neurology at the Vita-Salute San Raffaele University. “Given its demonstrated efficacy and safety profile, Zeposia represents an important new treatment option that I am excited to offer my patients.”

BMS’ Chief Medical Officer Dr Samit Hirawat also commented on the approval: “Today’s European Commission approval provides the opportunity for patients with RRMS with active disease to be offered Zeposia as a new first-line treatment option, which is an important advancement based on Phase 3 trial results showing significant improvements in relapses and brain lesions caused by this devastating disease. We share this achievement with the courageous multiple sclerosis patient community in Europe and around the globe, and are working closely with all stakeholders to ensure that eligible European patients can start benefitting from Zeposia as quickly as possible.”

Matt Fellows

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