The U.S. Food and Drug Administration (FDA) has approved Novartis‘ Kesimpta (ofatumumab) as a self-administered treatment for adults with relapsing forms of multiple sclerosis (MS), meaning those with clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS).
According to Novartis, Kesimpta is the first approved MS therapy targeting B-cells that can be taken at home via an under-the-skin (subcutaneous) injection, using an autoinjector pen, once a month. The medication is expected to be available to patients in the U.S. in early September.
“Multiple sclerosis (MS) is a complex disease, and response to disease modifying treatment will vary among individuals. This makes it important to have a range of treatments available with different mechanisms of action and routes of administration, said Bruce Bebo, PhD, executive vice president of research at the National MS Society.
“We are pleased to have an additional option approved for the treatment of relapsing forms of MS,” Bebo added.
Kesimpta is an antibody targeting a protein called CD20, which is found on the surface of immune system B-cells. While the exact mechanism of action is not fully understood, it is thought Kesimpta works by lowering the amount of B-cells that drive damaging inflammation in the nervous system and contribute to MS development.
The medication is administered once monthly in a precise dose using the Sensoready autoinjector pen, a procedure that can be done at the home. This contrasts with other B-cell-targeting therapies used in MS, which typically are given at hospitals or infusion treatment centers, a limitation that both raises healthcare costs and can be burdensome to patients.
No premedication is needed to take Kesimpta. The first injection is performed under the guidance of a healthcare professional. The first doses are given at weeks 0, one and two, before moving to monthly injections.
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