Kesimpta

Arzerra (ofatumumab) is a humanized anti-CD20 monoclonal antibody that binds to CD20 on the surface of B cells to eliminate B cells from the blood circulation. It was approved by the FDA in 2009 for the treatment of chronic lymphocytic leukemia (CLL) and is sold under the brand name Arzerra.

Kesimpta (ofatumumab), OMBI157, is the first B-cell targeted therapy that can be self-injected by patients once a month at home through the Sensoready automatic injection pen. It is used to treat multiple sclerosis (MS) and is sold under the brand name Kesimpta.

On August 20, 2020, Novartis announced that the US FDA has approved Kesimpta (ofatumumab) as a subcutaneous injection drug for the treatment of adult patients with relapsing multiple sclerosis (RMS), including clinically isolated syndrome, relapsing/remitting disease and active secondary progressive disease.

The approval of Kesimpta (ofatumumab) was based on the results of the Phase 3 clinical trials ASCLEPIOS I and II. In these studies, Kesimpta significantly reduced patient annualized relapse rates (ARR) and confirmed worsening of disability, and reduced active or new brain injury compared with approved oral therapies.

December 22, 2021, Shanghai - Novartis announced that the State Food and Drug Administration approved Panxinda uAE (ofatumumab) as a subcutaneous dosage form for the treatment of relapsing multiple sclerosis (RMS) in adults, including clinically isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis. Quanxinda%uAE is a B cell therapy with targeted, precise dosage and delivery. Studies have shown that ofatumumab can significantly reduce the annual recurrence rate and overall risk of disability progression, and has a good safety profile. It is considered to be the first choice for the treatment of RMS. It is worth mentioning that it is also the first and only B cell therapy in the world that patients can self-administer once a month, providing convenience for patient treatment.

The approval of ofatumumab was based on the results of two phase III clinical trials, ASCLEPIOS I and ASCLEPIOS II. The study included more than 1,800 patients, and the results showed that ofatumumab reduced Gd+T1 lesions by 98% compared with the active control group. In the second year of ofatumumab treatment, nearly 90% of patients achieved the composite treatment goal of no recurrence, no new or expanded MRI lesions, and no progression of disability. From the perspective of long-term disease control, the ASCLEPIOS study showed that the annual recurrence rate in the ofatumumab group was 0.11, which is equivalent to only one recurrence every 10 years.

In terms of safety, ofatumumab has gone through 18 years of unremitting exploration in research and development. Based on the original intravenous high-dose anti-CD20 monoclonal antibody, it has passed the three major innovations of "fully human source, low-dose equivalent and subcutaneous administration". The new mechanism strives to provide MS patients with a disease-modifying treatment (DMT) drug that is both safe and efficient. Its 3.5-year extended study data shows that ofatumumab can maintain IgG levels for a long time, is well tolerated, and has a low incidence of serious adverse events. In addition, compared with traditional oral DMT drugs, monoclonal antibody drugs have no liver and kidney toxicity and are safer.