ASCLEPIOS

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…

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,…

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…

#ACTRIMS2020 – Ofatumumab Self-injection Pen May Be ‘Very Attractive’ Option for Relapsing MS

Monthly under-the-skin injections of Novartisā€™Ā 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…

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…

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…