FDA approves Kesimpta to treat multiple sclerosis.- Novartis

Novartis announced that the 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 patient. 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 RMS6. Traditionally, B-cell treatments, which bind to and deplete B-cells associated with disease activity in MS, have predominantly been available in hospitals or infusion treatment centers, which can add costs to the healthcare system and present a lifestyle burden for some patients. Kesimpta provides patients the flexibility of self-administering via once-monthly subcutaneous dosing requiring no premedication, eliminating the need to travel to an infusion center. The positive results from the APLIOS study—an open-label Phase II study to determine the bioequivalence of subcutaneous delivery of Kesimpta via a prefilled syringe and a Sensoready pen in patients with RMS—and the ASCLEPIOS studies show Kesimpta to be a highly effective B-cell therapy that can be easily self-administered at home.