Ofatumumab

An intravenous (into-the-vein) formulation of ofatumumab — a disease-modifying therapy for multiple sclerosis (MS) sold under the brand name Kesimpta — resulted in a 63% reduction in relapse rates among MS patients, with about 60% remaining relapse-free over the first year of treatment, a recent study in…

Multiple sclerosis (MS) patients treated with rituximab were more than five times less likely to experience a relapse compared with patients given Tecfidera (dimethyl fumarate), according to data from a Phase 3 clinical trial. Patients on the experimental therapy also were 32% more likely to have no evidence…

Kesimpta (ofatumumab) may be more effective at reducing relapse rates than other disease-modifying therapies (DMTs) in Japanese adults with relapsing forms of multiple sclerosis (MS), according to a review of clinical trial data. Although the differences were not statistically significant, the study provided comparative evidence that may help…

People with relapsing forms of multiple sclerosis (MS) who were continuously on Kesimpta (ofatumumab) for up to four years were about four times more likely to have no evidence of disease activity than those initially on Aubagio (teriflunomide), according to updated data from the ASCLEPIOS and ALITHIOS…

Kesimpta (ofatumumab) is now accessible to eligible Canadians with relapsing-remitting multiple sclerosis (RRMS) through public drug plans in Ontario and Quebec. The treatment has been included as an exceptional medication under both the Ontario Drug Benefit Exceptional Access Program and the Régie de l’assurance maladie du Québec. This…

Treatment with Kesimpta (ofatumumab) for more than three years revealed no new or unexpected safety findings, and continued to slow disability progression and prevent the development of new brain lesions in people with relapsing multiple sclerosis (MS), according to new clinical trial data. Information from another trial also…

Ocrevus (ocrelizumab) continues to be the most commonly prescribed therapy for progressive forms of multiple sclerosis (MS), including primary progressive MS (PPMS) and secondary progressive MS (SPMS), according to an analysis from the market intelligence firm Spherix Global Insights. However, other therapies are “gaining traction” among…

National MS Society Supports Stem Cell Transplant for Select, Aggressive RRMS Bravo! This statement is welcome after the recommendation of National Multiple Sclerosis Society advisers that autologous hematopoietic stem cell transplant, or AHSCT, could be useful for people younger than 50 and recently diagnosed with MS. Now, how long…

Anti-CD20 antibody therapies that target B-cells are highly effective for reducing the risk of relapses in people with relapsing-remitting multiple sclerosis (RRMS), a new analysis confirms. The analysis did not find any significant differences in efficacy or safety among the anti-CD20 therapies currently approved to treat RRMS, though…

While people with multiple sclerosis (MS) taking anti-CD20 therapies do not mount a robust antibody response after getting vaccinated against COVID-19, the vaccines do strongly activate other parts of the immune system that are likely to be helpful in fighting the virus, a new study shows. “The message…

Adults in Scotland with active relapsing-remitting multiple sclerosis (RRMS) will now have access at low or no cost to Kesimpta (ofatumumab), the first self-administered, at-home B-cell-targeting therapy for people with the neurodegenerative disease. The Scottish Medicines Consortium (SMC) recommended that the Novartis therapy be available through the…

Long-term use of Kesimpta (ofatumumab) among people with multiple sclerosis (MS) did not substantially lower their antibody levels, allowing them to retain an ability to fight infections, new data from a Phase 3 clinical trial indicate. “These long-term results continue to support Kesimpta as a high-efficacy, first-choice treatment with…

Editor’s note: The Multiple Sclerosis News Today team is providing in-depth coverage of the 2021 Virtual AAN Annual Meeting, April 17–22. Go here to read the latest stories from the conference. Note: This story was updated April 21, 2021, to clarify that Kesimpta will be available in the next three months…

Kesimpta (ofatumumab) has been approved in the U.K. as the first self-administered, at-home, B-cell-targeting therapy for people with relapsing forms of multiple sclerosis (MS) and active disease. More specifically, the approval includes patients with either clinically isolated syndrome, relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS), who have…

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),…

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…

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…

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…

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 Seen as Superior to Aubagio at Lowering Relapse Rates in Phase 3 Trials Ofatumumab is a cancer medication that’s awaiting approval by the U.S. Food and Drug Administration and the European Medicines Agency to treat MS patients. It’s delivered by injection once a month and aims to reduce…

Novartis‘ ofatumumab outperformed Aubagio (teriflunomide) at lowering the frequency of relapses and preventing disability progression among people with relapsing forms of multiple sclerosis (MS), a study based on clinical trial data reports. The study, “Ofatumumab versus Teriflunomide in Multiple Sclerosis,” was published in…

FDA Extends Review of Ofatumumab for Relapsing MS to September The U.S. Food and Drug Administration (FDA) was expected to make a decision about ofatumumab, a self-administered injection of a monoclonal antibody, by this month. Now, it looks as if we’ll be waiting until fall. Ofatumumab is already approved…

The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘ ofatumumab, a possible self-administered injection therapy for relapsing multiple sclerosis (MS), the company announced. Originally expected in June, the FDA decision is now expected in September. “Novartis will continue to work with the FDA to…

Air Pollution of Urban Life Raises MS Risk, Study from Italy Suggests I grew up in New York City. It’s hard to get more urban than that. There weren’t many factories spewing pollution, but there certainly were a lot of cars, trucks, and buses, and I inhaled more than…

Ofatumumab (OMB157) elicits a strong and fast reduction in the levels of circulating immune cells in people with relapsing forms of multiple sclerosis (MS), effectively helping to stop disease activity, according to new data from the Phase 2 APLIOS trial. The medication was also found to be more…