Is Ofatumumab on the market?

Ofatumumab (Ofatumumab) is available for intravenous administration and is a fully human monoclonal antibody directed against CD20 that appears to rapidly deplete B cells. In 2009, it was approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain types of chronic lymphocytic leukemia (CLL) under the trade names Arzerra and Kesimpta. In the United States, as well as in the European Union and elsewhere, it is sold under the brand nameKesimpta and is approved to treat multiple sclerosis (MS).

In a Phase III clinical trial of subjects with relapsing forms of multiple sclerosis (RMS), subcutaneous injections of ofatumumab reduced the number of relapses and delayed disease progression. In February 2020, the FDA and EMA respectively approved the supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA) of ofatumumab for the treatment of RMS in adults. Ofatumumab has also been studied for potential therapeutic use in various lymphomas and rheumatoid arthritis.

Ofatumumab The original drug has been approved for domestic marketing in 2021, but it is only used to treat multiple sclerosis. It has also been included in medical insurance and is limited to patients who meet the indications for reimbursement. The price is around tens of thousands of yuan, and the trade name is Quanxinda. The European version of ofatumumab sold overseasoriginal drug specifications20mg/0.4mL may cost around RMB 16,000 per vial (the price may fluctuate due to the exchange rate). It is expensive and there is currently no generic version of ofatumumab for sale. For more drug information and specific prices, please consult a medical consultant.