The USFDA has recently approved ublituximab  to treat relapsing forms of multiple sclerosis (RMS) in adults. The approval was granted based on the findings of the ULTIMATE I & II phase 3 trials. Clinical trials The ULTIMATE I & II were randomized, active comparator-controlled, double-blind, and double-dummy trials conducted on 1,094 patients with RMS in ten countries and for 96 weeks. The patients were administered ublituximab (150 mg, IV infusions in  1 hour), teriflunomide (14 mg, daily oral dose), or oral/IV placebo.

Ublituximab significantly reduced the annualized relapse rate , 12-week confirmed disability progression , and the number of T1 gadolinium-enhancing lesions per MRI and new or enlarging T2 hyperintense lesions per MRI compared to teriflunomide (Table 1). Table 1 . Results from the ULTIMATE I and II trials comparing the efficacy of ublituximab and teriflunomide. …