(RTTNews) – Biogen Inc. (BIIB) said results from phase 3b NOVA Study showed that every six-week natalizumab IV administration provides a high level of efficacy in controlling Multiple Sclerosis disease activity in patients who switched from the approved every four-week dosing regimen.
The two-year phase 3b NOVA study, dubbed as NCT03689972, evaluated every six-week dosing with natalizumab in relapsing-remitting multiple sclerosis.
The company noted that the study was designed to estimate a potential difference between the efficacy of every six-week (Q6W) 300mg natalizumab intravenous (IV) administration compared to the efficacy of the approved every four-week (Q4W) dose in people treated with TYSABRI for relapsing-remitting multiple sclerosis (MS) after at least one year of disease stability on a Q4W IV dosing schedule.
The primary endpoint showed a numerical difference between the mean number of new or newly enlarging T2 hyperintense lesions at week 72 of 0.05 (Q4W) and 0.20 (Q6W) \, which based on the full trial results is not clinically meaningful. The numerical difference was driven by a high number of lesions occurring in two participants in the Q6W arm.
There were no statistically significant or clinically meaningful differences in secondary endpoints at week 72 between the Q4W and Q6W treatment arms, and disease activity was well-controlled in both arms.
The company noted that a complete analysis of the study data is ongoing and detailed results will be shared in a future scientific forum. Natalizumab is available commercially under the brand name TYSABRI and the only approved dose is 300mg on a Q4W regimen.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.