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Novartis receives EU approval for Kesimpta® (ofatumumab), self-administered, targeted B-cell therapy for adult patients with relapsing MS

Posted in Industry News on 1st Apr 2021

  • There are more than 1 million people living with multiple sclerosis (MS) in Europe1, Kesimpta® (ofatumumab) addresses the current unmet need for a high-efficacy disease-modifying therapy (DMT) that combines powerful efficacy and favourable safety profile with the flexibility of self-administration at home via the Sensoready® autoinjector pen2,3
  • Approval based on two Phase III ASCLEPIOS studies that met primary endpoints where Kesimpta showed a reduction of annual relapses by over 50% versus teriflunomide, a first-line treatment in MS, and achieved more than 30% relative risk reduction of 3-month confirmed disability progression2
  • Kesimpta may halt new disease activity in relapsing forms of MS (RMS) patients, as shown in post hoc analysis, where nearly nine out of 10 patients treated with Kesimpta achieved no evidence of disease activity (NEDA-3) in their second year of treatment4
  • EU approval follows recent approvals for Kesimpta including the US, Canada, Switzerland, Singapore, Australia and Japan

Novartis announced on March 30th 2021 that the European Commission has approved Kesimpta® (ofatumumab) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults with active disease defined by clinical or imaging features. Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that has shown superior efficacy with a similar safety profile compared with teriflunomide, a first-line treatment in MS2. Kesimpta is the first B-cell therapy that can be self-administered once-monthly at home via the Sensoready® autoinjector pen and can be a first-choice treatment option for patients with RMS3.

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

Pedro Carrascal, President of the European Multiple Sclerosis Platform (EMSP).

“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. Additionally, as RMS progresses, it can substantially increase overall healthcare costs as a result of increased disability,” said Haseeb Ahmad, Global Head of Value & Access, Novartis Pharmaceuticals. “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 therapies. 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.”

About Kesimpta® (ofatumumab)

Kesimpta is a targeted, precisely dosed and delivered B-cell therapy that provides the flexibility of self-administration for adults with relapsing forms of multiple sclerosis (RMS). It is an anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly injection, delivered subcutaneously2,3. Initial doses of Kesimpta are at Weeks 0, 1 and 2, with the first injection performed under the guidance of a healthcare professional. As shown in preclinical studies, Kesimpta is thought to work by binding to a distinct epitope on the CD20 molecule inducing potent B-cell lysis and depletion5. The selective mechanism of action and subcutaneous administration of Kesimpta allows precise delivery to the lymph nodes, where B-cell depletion in MS is needed, and preclinical studies have shown that it may preserve the B-cells in the spleen6. Once-monthly dosing of Kesimpta differs from other anti-CD20 therapies as it allows faster repletion of B-cells, offering more flexibility in MS management7. Ofatumumab was originally developed by Genmab and licensed to GlaxoSmithKline. Novartis obtained rights for ofatumumab from GlaxoSmithKline in all indications, including RMS, in December 20158.

Novartis is working closely with all stakeholders to ensure that eligible European patients can start benefitting from this treatment as quickly as possible. In August 2020, the US Food and Drug Administration approved Kesimpta as an injection for subcutaneous use for the treatment of RMS, to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in adults. Additionally, Kesimpta has been approved for the treatment of relapsing forms of multiple sclerosis in Canada, Switzerland, Singapore, Australia, Japan, Argentina, United Arab Emirates, Albania, and India.

References

  1. Multiple Sclerosis International Federation. Atlas of MS 2020-Mapping multiple sclerosis around the world. Available from: https://www.msif.org/wp-content/uploads/2020/10/Atlas-3rd-Edition-Epidemiology-report-EN-updated-30-9-20.pdf  [Last accessed: March 2021].
  2. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis. N Engl J Med. 2020;383(6):546-557.
  3. Bar-Or A, Fox E, Goodyear A, et al. Onset of B-cell depletion with subcutaneous administration of ofatumumab in relapsing multiple sclerosis: results from the APLIOS bioequivalence study. Poster presentation at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum; February 27-29, 2020; West Palm Beach, FL.
  4. Hauser S, Bar-Or A, Cohen J, et al. Ofatumumab versus teriflunomide in relapsing multiple sclerosis: analysis of no evidence of disease activity (NEDA-3) from ASCLEPIOS I and II trials. Eur J Neurol. 2020;27(S1):85-86.
  5. Smith P, Kakarieka A, Wallstroem E. Ofatumumab is a fully human anti-CD20 antibody achieving potent B-cell depletion through binding a distinct epitope. Poster presentation at: ECTRIMS; September 2016; London, UK.
  6. Smith P, Huck C, Wegert V, et al. Low-dose, subcutaneous anti-CD20 therapy effectively depletes B-cells and ameliorates CNS autoimmunity. Poster presentation at: ECTRIMS; September 2016; London, UK.
  7. Savelieva M, Kahn J, Bagger M, et al. Comparison of the B-cell recovery time following discontinuation of anti-CD20 therapies. ePoster presentation at: ECTRIMS; October 2017; Paris, FR.
  8. Genmab Press Release: Genmab announces completion of agreement to transfer remaining ofatumumab rights. December 21, 2015. Accessed March 9, 2021. https://ir.genmab.com/static-files/9d491b72-bb0b-4e46-a792-dee6c29aaf7d .

See this press release on the Novartis website.