Biogen Inc. announced new data from its industry-leading portfolio of multiple sclerosis (MS) therapies. These data include additional results from the NOVA study on the efficacy of every six-week (Q6W) 300mg natalizumab intravenous (IV) administration, results from a comparative real-world evaluation of TYSABRI® (natalizumab) when compared to Ocrevus®(ocrelizumab), as well as outcomes on GI tolerability, persistence and adherence for VUMERITY® (diroximel fumarate). The studies are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021. New late-breaking data from the Phase 3b NOVA study provide additional insights into the efficacy of every six-week (Q6W) 300mg natalizumab IV administration compared to the approved every four-week (Q4W) dose of TYSABRI (n=499) for relapsing-remitting multiple sclerosis. Topline results from the NOVA study were released in August 2021, showing that every six-week administration provides a high level of efficacy in controlling MS disease activity in patients who switched to Q6W after at least one year of disease stability on the approved Q4W IV dosing schedule. New results of exploratory outcomes and additional secondary endpoints presented at ECTRIMS demonstrate that efficacy is maintained on a Q6W schedule: Time to first relapse was similar between the two dosing schedules with the proportion who were relapse-free at 72 weeks at 96.9% for Q6W and 97.6% for Q4W; The proportion of patients free of disability worsening was 90.0% in the Q6W arm and 92.0% in the Q4W arm; Disease activity rates were similar between both groups. The proportion of patients with No Evidence of Disease Activity (NEDA) was 70.0% for Q6W and 67.4% for Q4W. NEDA was defined as no gadolinium enhancing (Gd+) lesions, no new or newly enlarging T2 hyperintense lesions, no relapse and no 24-week confirmed disability worsening (CDW) at 72 weeks. Patients with one or more missing assessments were counted as having not achieved NEDA; The safety findings in the NOVA study were consistent with the known safety profile of IV natalizumab, and the incidence of AEs and SAEs were similar between the two treatment arms. One patient with asymptomatic progressive multifocal leukoencephalopathy (PML) in the Q6W arm was high-risk based on the known risk factors, underscoring the importance of the need for continued PML monitoring and risk factor considerations in patients treated with natalizumab. The NOVA study was designed to assess the efficacy of Q6W dosing with natalizumab IV administration following analyses from the TOUCH (TYSABRI Outreach: Unified Commitment to Health) Prescribing Program, which showed that extended interval dosing was associated with a significant reduction in the probability of PML.4 Natalizumab is available commercially under the brand name TYSABRI and the only approved dose is 300mg on a Q4W regimen.