Ofatumumab (Genmab/Novartis) is a fully human immunoglobulin G1 and high-affinity antibody that targets a novel epitope on cluster of differentiation (CD)20 on the B-cell membrane. Ofatumumab binds effectively to both the small and large extracellular loops on CD20 and releases very slowly over time. Preclinical and clinical data have demonstrated that ofatumumab effectively depletes B cells, some of the major cells involved in the autoimmune responses seen in multiple sclerosis (MS). Being a fully human monoclonal antibody, ofatumumab also shows potential for low immunogenicity, and its efficacy is less likely to diminish during prolonged treatment.
Ofatumumab was originally developed by Genmab, and is currently marketed and developed in collaboration with Novartis. Ofatumumab is already approved for the treatment of chronic lymphocytic leukemia in both the US and Europe, where it is marketed as Arzerra. In MS, the drug entered Phase III development in September 2016. Novartis is conducting ofatumumab’s pivotal studies in relapsing MS, and the company plans to file for approval in 2019.
LIST OF FIGURES
7 Figure 1: Ofatumumab for multiple sclerosis – SWOT analysis
8 Figure 2: Datamonitor Healthcare’s drug assessment summary of ofatumumab for multiple sclerosis
9 Figure 3: Datamonitor Healthcare’s drug assessment summary of ofatumumab for multiple sclerosis
LIST OF TABLES
5 Table 1: Ofatumumab drug profile
6 Table 2: Ofatumumab Phase III trials in multiple sclerosis
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