Novartis under-skin injection of CD20 antibodies is FDA approved to treat multiple sclerosis.

MS is a chronic disease of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerve and spinal cord through inflammation and tissue damage.
progression of MS leads to increased loss of physical function (e.g. walking) and cognitive function (e.g. memory).
there are three main types of relapsed relapsed MS (RRMS), secondary progress MS (SPMS), and primary progress MS (PPMS).
RMS is characterized by a well-defined recurrence and remission process, i.e. recurrence, seizure or deterioration, followed by a partial or full recovery period.
, there are about 2.3 million MS patients worldwide, and about 85% of MS patients are initially diagnosed with RMS.
image source: Ref. Ofatumumab is an all-humanized monoclonal antibody that targets CD20 and achieves the effect of removing B cells from the blood circulation by binding to CD20 on the surface of B cells.
was first approved by the FDA in 2009 for the treatment of chronic lymphocytic leukemia (CLL), administered intravenously at high doses by healthcare providers.
because of the critical role of B cells in autoimmune diseases, Novarma has launched a new development project to study the effects of ofofatumumab in treating RMS.
clinical development project to treat RMS with Ofatumumab took 10 years and involved more than 2,300 patients worldwide.
Kesimpta works in a unique way, and drug-giving programs specifically designed for RMS play a key role in treatment outcomes.
this is different from previously approved administration programmes and routes for CLL adaptation.
kesimpta is based on trial results from Phase 3 clinical trials ASCLEPIOS I and II.
these studies, Kesimpta significantly reduced the annual recurrence rate (ARR) and confirmed increased disability compared to approved oral therapies, reducing active or new brain injury.
the results of both studies were most recently published in the August 6, 2020 issue of the New England Journal of Medicine.
references: s1. FDA approvals Novartis Kesimpta® (ofatumab), the first and only self-administration, targeted B-cell therapy for patients with relapsing multiple sclerosis. Retrieved August 20, 2020, from .2, Understanding relapsing forms of multiple sclerosis. Retrieved August 20, 2020, from.