Novartis AG's Arzerra was shown to be better than Sanofi's Aubagio in two late-stage studies in adults with relapsing forms of multiple sclerosis.
MS is a disease of the brain and spinal cord where the immune system attacks the protective sheath that covers nerve fibers, causing communication problems between the brain and the rest of the body. The relapsing-remitting type of the disease is characterized by flare-ups of symptoms, followed by a period of recovery.
Arzerra, or ofatumumab, produced a highly significant and clinically meaningful reduction in the number of confirmed relapses in MS patients better than Aubagio, or teriflunomide, in two head-to-head studies — meeting the trials' main goals. The studies, called Asclepios I and Asclepios II, are twin, identical design trials which enrolled 1,882 patients between the ages of 18 and 55 years with relapsing multiple sclerosis.
Swiss drugmaker Novartis said the efficacy and safety of Arzerra was consistent with the observations from prior phase 2 studies of the drug. The company plans to initiate submissions to health authorities by the end of 2019.
Novartis obtained the rights to develop and commercialize ofatumumab in 2015 under a license from Genmab A/S.
