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.
Novartis is now working closely with all European stakeholders to accelerate patient access to the therapy. Health authorities in each European Union member country will now decide whether to add Kesimpta to their respective public health programs, which allow patients to access treatments at low or no cost.
The decision comes less than two months after the Committee for Medicinal Products for Human Use, an arm of the European Medicines Agency, recommended its approval. It also follows similar decisions in the U.S., Canada, Switzerland, Singapore, Australia, Japan, Argentina, United Arab Emirates, Albania, and India.
In contrast to other B-cell-targeting therapies used in MS, which are delivered directly into the bloodstream at hospitals or specialist infusion centers, Kesimpta can be self-administered under the skin, at home, using the Sensoready autoinjector pen. This eliminates the need to travel to receive treatment and the costs involved in doing so.
Kesimpta’s regimen includes three weekly doses initially, followed by monthly injections; the first injection must be performed under the guidance of a healthcare professional.
“Kesimpta’s powerful efficacy and favorable safety profile has the potential to become a first-choice treatment to help improve the quality of life of people living with MS, as well as having broader value in potentially reducing medical costs associated with infusion [into-the-vein] therapies,” Haseeb Ahmad, Novartis’ global head of value and access, said in a press release.
Pedro Carrascal, president of the European MS Platform, said that “with more than 1 million people living with MS — an incurable condition so far — in Europe, it is encouraging to see that research continues to develop more treatments.”
“We welcome the approval from the European Medicines Agency that gives another treatment option for people living with RMS [relapsing MS],” Carrascal added.
Kesimpta is an antibody that binds to the CD20 receptor at the surface of B-cells — a type of immune cell involved in the abnormal immune responses that drive MS — promoting their death.
Its approval was based on results from the ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) Phase 3 clinical trials, which compared Kesimpta with Aubagio (teriflunomide) in a total of 1,882 people with relapsing MS.
Aubagio, Sanofi Genzyme’s oral treatment for relapsing forms of MS, is thought to work by blocking the activity of B-cells and T-cells, another type of immune cell involved in MS.
Findings from both trials showed that, compared with Aubagio, Kesimpta significantly reduced patients’ annual relapse rate by more than 50% and their relative risk of disability progression after three months by more than 30%.
“Slowing the worsening of disability is one of the main goals when managing RMS and evidence shows that early initiation of a high-efficacy treatment can improve long-term outcomes,” Ahmad said.
Kesimpta was also associated with fewer brain lesions on MRI scans, suggesting less extensive brain damage among those taking the therapy. The medications had comparable safety profiles.
In addition, a post hoc analysis — which is performed after a trial is completed — showed that nearly nine out of 10 Kesimpta-treated patients had no evidence of disease activity in their second year of treatment, Novartis reported.
“Kesimpta is a testament to our commitment to reimagine medicine and we remain dedicated to helping to improve the lives of people living with this disease,” Ahmad said.
In a separate press release, Jan van de Winkel, PhD, CEO of Genmab, the therapy’s initial developer, said that the company is “extremely pleased that Kesimpta is now approved in both Europe and in the U.S., providing [relapsing MS] patients with a convenient, efficacious and safe treatment option.”
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