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Novartis Kesimpta approved for relapsing multiple sclerosis in the US

The US Food and Drug Administration has approved Kesimpta (ofatumumab) for treating patients with relapsing multiple sclerosis. Novartis announced that Kesimpta is the first and only self-administered, targeted B-cell therapy. The drug is available as a subcutaneous dosage form, which can be administered at home. The drug can be administered at home via the Senoready autoinjector pen.

The drug acts by targeting B-cells, delete lymph B-cells, thereby suppressing the immune responses, which are responsible for multiple sclerosis.

The approval is based on Phase 3 ASCLEPIOS studies, in which the efficacy of 20 mg subcutaneous form of Kesimpta has demonstrated superiority versus teriflunomide 14 mg oral dosage forms. The drug has shown a reduction in the annualized relapse rate, 51% reduction versus teriflunomide in ASCLEPIOS I trial, and 59% reduction in relapse rate versus teriflunomide in ASCLEPIOS II trial. With the administration of Kesimpta, there was significant reduction in Gd+ T1 lesions and new or enlarging T2 lesions.

Kesimpta (ofatumumab) is an anti-CD20 monoclonal antibody. The drug has been submitted as supplemental drug application. The drug has loading doses at week 0, 1, and 2 followed monthly once subcutaneous injection. The drug were originally developed by Genmab, which was later acquired GSK. Novartis has received the rights for the product including multiple sclerosis from GSK in 2015.

Multiple sclerosis:

Multiple sclerosis is an inflammatory disease of the nervous system characterized by myelin depletion. Despite the availability of several disease-modifying agents, patients with multiple sclerosis experience disease activity.


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