FDA approves Novartis Kesimpta? (ofatumumab), the first and only self-administered, targeted B-cell therapy for patients with relapsing multiple sclerosis

發(fā)布時間： 2020-08-31 閱讀：844次

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August 20, 2020 ― Novartis today announced that the US Food and Drug Administration (FDA) has approved Kesimpta? (ofatumumab, formerly OMB157) as an injection for subcutaneous use for the treatment of relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide and is a first-choice treatment option for RMS patients. Kesimpta is the first B-cell therapy that can be self-administered once monthly at home via the Sensoready? autoinjector pen.

One of the goals when managing RMS is to preserve neurological function to slow down the worsening of disability. Despite the availability of several disease-modifying therapies (DMTs) for the treatment of RMS, the majority of individuals with RMS continue to experience disease activity. Evidence suggests early initiation of high-efficacy treatment can improve long-term outcomes for patients with RMS.

“At Novartis, we challenge treatment paradigms and strive to offer the best treatment choice for patients,” said Marie-France Tschudin, President, Novartis Pharmaceuticals. “When treating patients with RMS, Kesimpta is a meaningful treatment option that delivers both high efficacy and safety with the ability for patients to have more freedom in managing their disease. The development of Kesimpta is a great example of our commitment, knowledge and understanding of multiple sclerosis, which enabled us to identify a targeted treatment that can significantly improve patient outcomes and experience.”