Efficacy and Safety of Natalizumab Maintained With Administration Every 6 Weeks

New data from the phase 3b NOVA study (NCT03689972) show efficacy is maintained with intravenous (IV) administration of 300 mg natalizumab (Tysabri; Biogen, Cambridge, MA) every 6 weeks compared to the approved every-4-week for relapsing-remitting multiple sclerosis (MS). Of participants treated every 6 weeks vs every 4 weeks, 96.9% annd 97.6%, respectively, were relapse free at 72 weeks. Additionally, 90.0% of those treated every 6 weeks and 92% of those treated every 4 weeks were free of disability progression. 

The NOVA study was designed to assess the efficacy of dosing every 6 weeks administration following analyses from the TOUCH Prescribing Program, which showed that extended interval dosing of natalizumab was associated with a significant reduction in the probability of progressive multifocal leukoencephalopathy (PML). 

“Upon complete evaluation of the NOVA data, the results inclusive of secondary and exploratory outcomes offer a more comprehensive understanding of the 6-week dosing regimen of natalizumab and its ability to provide a high level of efficacy in controlling MS disease activity,” said John Foley, MD, Rocky Mountain MS Clinic. “Combined with the improvement in safety demonstrated through analyses of data from the TOUCH Prescribing Program, which has shown that a 6-week dosing schedule is associated with an 88% reduction in the risk of PML, these data on the efficacy of every-6-week dosing offer valuable information for clinicians.”

Safety findings in the NOVA study were consistent with the known safety profile of natalizumab, and the incidence of adverse events or serious adverse events were similar between the 2 treatment arms.