February 1, 2021 News by Marisa Wexler, MS CHMP Favors Kesimpta for Adults With Relapsing MS in Europe A branch of the European Medicines Agency (EMA) has recommended thatĀ 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…
September 11, 2020 News by Marta Figueiredo, PhD #MSVirtual2020 – Novartis to Present Latest Data on Kesimpta, Mayzent and Gilenya Novartis will present the latest clinical data on three of its approved multiple sclerosis (MS) therapies ā Kesimpta (ofatumumab), Mayzent (siponimod), and Gilenya (fingolimod) ā at the Ā MSVirtual2020 meeting that opens today. The 8th joint meeting of the Americas Committee for Treatment and…
September 1, 2020 News by Marisa Wexler, MS Kesimpta Meets Safety, Efficacy and Flexibility Needs of Relapsing MS, Experts Say 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…
August 21, 2020 News by Marisa Wexler, MS FDA Approves Kesimpta, B-cell Targeting Therapy for Relapsing MS 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 withĀ clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), and active secondary progressive MS (SPMS). According to Novartis,…
June 4, 2020 News by Marisa Wexler, MS FDA Extends Review of Ofatumumab for Relapsing MS to September The U.S. Food and Drug Administration (FDA) is extending its review of Novartis‘Ā ofatumumab, a possible self-administered injection therapy for relapsingĀ 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…
May 29, 2020 News by Joana Carvalho, PhD Ofatumumab Lowers B-cell Counts and Helps Relapsing MS Patients Reach NEDA, Data Show 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…
March 13, 2020 News by Marta Figueiredo, PhD #ACTRIMS2020 – Ofatumumab Self-injection Pen May Be ‘Very Attractive’ Option for Relapsing MS Monthly under-the-skin injections of NovartisāĀ investigational candidate ofatumumab show promise as a convenient, effective, and safe therapeutic option for people with relapsing multiple sclerosisĀ (MS). Data from the ASCLEPIOS and APLIOS clinical trials showed that ofatumumab ā currently under regulatory review for possible approval in the U.S. and Europe…
February 25, 2020 News by Patricia Inacio, PhD Novartis’ Ofatumumab for Relapsing MS Up for Possible Approval by FDA and EMA Both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) will review Novartis‘ applications seeking regulatory approval of ofatumumab, anĀ investigational B-cell therapy for the treatment of relapsing forms ofĀ multiple sclerosisĀ (MS) in adults. Novartis’ applications for ofatumumab ā which has the…
October 15, 2019 News by Ana Pena PhD #ECTRIMS2019 – Ofatumumab Part of ‘Magnificent Success Story’ for MS, ASCLEPIOS Trial Investigator Says Ofatumumab, anĀ 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…
September 17, 2019 News by Ana Pena PhD #ECTRIMS2019 ā Ofatumumab Superior to Aubagio in Lowering Relapse Rates and Lesions, Data Show Monthly under-the-skin injections of ofatumumab are superior to AubagioĀ (teriflunomide) to treat relapsing-remitting multiple sclerosis (RRMS) and secondary progressive multiple sclerosis (SPMS), leading to over 50% reduction in relapse rates, and more than a 90% reduction in active brain lesions, compared with Aubagio, results from ASCLEPIOS I…
September 3, 2019 News by Jose Marques Lopes, PhD Ofatumumab Better at Easing Relapse Rates and Slowing MS Progression Than Aubagio, Phase 3 Data Show Monthly injections of ofatumumabĀ led to more clinically meaningful reductions in relapse rates and delayed disability progression than did daily treatment withĀ AubagioĀ (teriflunomide) tablets in people with relapsing forms of multiple sclerosisĀ (MS), results from two Phase 3 trials showed. Ofatumumab, formerly known as OMB157, is a potent, self-administered…
June 13, 2016 News by Patricia Silva, PhD Genmab to Begin Phase 3 Trials of Ofatumumab to Treat Relapsing Multiple Sclerosis GenmabĀ announced plans to soon begin a Phase 3Ā clinical trial program assessing the subcutaneous formulation of ofatumumabĀ as a potential treatment forĀ relapsing multiple sclerosis (MS). The company, workingĀ in collaboration with its partnerĀ Novartis, will begin enrolling patients in September in trials that willĀ evaluate the efficacy and safety of ofatumumab compared…