The European Commission has approved Novartis’ Kesimpta (ofatumumab) as the first self-administered, at-home B-cell-targeting therapy for adults with relapsing forms of multiple sclerosis (MS) and active disease. Active disease in these forms, which include clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS),…
Kesimpta
Health Canada has approved Kesimpta (ofatumumab) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease, as defined by clinical and imaging features. In contrast with other B-cell-targeting therapies used in MS, patients can self-administer a precise dose of Kesimpta at home using the Sensoready…
People with multiple sclerosis (MS) and their nurses prefer the Sensoready autoinjector pen for subcutaneous self-administration of Kesimpta (ofatumumab) over other methods for injecting treatments, according to a survey. The survey was conducted by Novartis, which markets Kesimpta. Full findings from the survey will be presented at…
A branch of the European Medicines Agency (EMA) has recommended that Kesimpta (ofatumumab) be approved and made available to treat relapsing forms of multiple sclerosis (MS) in adults with active disease. A final decision from the European Commission (EC) is expected in about two months. Typically, the EC follows…
Kesimpta (ofatumumab), the first self-administered B-cell therapy to treat relapsing forms of multiple sclerosis (MS), is now available via AllianceRx Walgreens Prime, one of the largest specialty and home delivery pharmacies operating in the U.S., to patients living in the country. The specialty pharmacy — which focuses on serving…
Novartis is not planning to open a clinical trial of Kesimpta (ofatumumab) as a potential treatment for primary progressive multiple sclerosis (PPMS) anytime soon, a company executive said. But it is well aware of the “unmet need” for therapy options among this patient group, and is exploring avenues. “We do…
Novartis will present the latest clinical data on three of its approved multiple sclerosis (MS) therapies — Kesimpta (ofatumumab), Mayzent (siponimod), and Gilenya (fingolimod) — at the  MSVirtual2020 meeting that opens today. The 8th joint meeting of the Americas Committee for Treatment and…
Upcoming and ongoing clinical trials aim to expand an understanding of Kesimpta (ofatumumab), the Novartis therapy recently approved by the U.S. Food and Drug Administration (FDA) to treat relapsing forms of multiple sclerosis (MS). Kesimpta is an anti-CD20 monoclonal antibody, a type of treatment that is thought to work…
Targeting B-cells in Cerebrospinal Fluid May Lead to More Effective MS Therapies, Study Suggests
Immune B-cells are more abundant and have a pro-inflammatory profile in the cerebrospinal fluid (CSF), the fluid that bathes the central nervous system,  compared to blood in people with relapsing-remitting multiple sclerosis (RRMS), a study reports. The results suggest that therapeutic strategies targeting the CSF B-cells could constitute a…
Kesimpta (ofatumumab) is a safe and effective treatment for relapsing multiple sclerosis (MS), with an ease of delivery that makes it more convenient than comparable therapies, experts say. Developed and marketed by Novartis, Kesimpta was recently approved by the…
MS News That Caught My Eye Last Week: Kesimpta, Ocrevus and Chickenpox, Generic Tecfidera, UTIs
FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS The U.S. Food and Drug Administration’s approval of Kesimpta (ofatumumab) this month is a pretty big deal. Kesimpta is a once-a-month injectable disease-modifying therapy. There’s nothing else like it, because Kesimpta targets B-cells in the immune system. Until now, only…
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,…
Ofatumumab, an investigational B-cell therapy being developed by Novartis, demonstrated encouraging results in lowering relapse rates and active brain lesions in people with relapsing multiple sclerosis (MS) enrolled in the ASCLEPIOS trials. For Stephen L. Hauser, MD, an investigator in the ASCLEPIOS trials, these results represent a…
The loss of immune B-cells, and the resulting changes in the profile of immune T-cells, is a major mechanism of action for the beneficial effects seen with ublituximab treatment in multiple sclerosis (MS) patients, a study suggests. B-cells are a type of immune cell best known for producing…