More specifically, the approval includes patients with either clinically isolated syndrome, relapsing-remitting MS (RRMS), or active secondary progressive MS (SPMS), who have been experiencing relapses or showing new lesions on MRI scans.
This approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) follows similar decisions in the E.U., the U.S., Canada, Switzerland, Singapore, Australia, Japan, Argentina, the United Arab Emirates, Albania, and India.
The U.K.’s National Institute for Health Care and Excellence (NICE) and the Scottish Medicines Consortium now will decide whether to add Kesimpta to their respective National Health Service (NHS), which would allow patients to access treatments at low or no cost. NICE’s decision is expected in the coming weeks, and a determination for Scotland will be issued later this year.
“We are very pleased that ofatumumab has been granted a UK licence,” David Martin, CEO of the MS Trust, said in an organization press release. “Ofatumumab is an effective treatment which people take at home once a month and will be a useful alternative to other disease modifying drugs which require treatment in hospital clinics.”
Kesimpta, developed by Novartis, is an antibody therapy that binds the CD20 receptor on the surface of immune B-cells — a type of immune cell involved in the abnormal immune responses that drive MS — promoting their death.
While its mechanism of action is similar to that of Ocrevus (ocrelizumab) and other B-cell targeted therapies, Kesimpta is the first treatment of its kind that can be self-administered at home, using the Sensoready autoinjector pen. This gives patients a more convenient method of taking the medication.
The three initial doses of Kesimpta are administered once a week, and treatment is given once a month thereafter. The first injection must be performed under the guidance of a healthcare professional.
“Ofatumumab can potentially give independence to a group of people who have previously had to rely upon regular medical visits to treat this life-changing condition,” Martin said in a Novartis press release.
“We hope ofatumumab will provide people living with relapsing forms of MS a sense of independence, and positively impact their lives by reducing their disease progression,” Martin added.
Kesimpta’s approval was based on data from two Phase 3 trials — ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231) — that compared the safety and effectiveness of Kesimpta to that of Aubagio (teriflunomide) in people with relapsing forms of MS.
Aubagio, by Sanofi Genzyme, is an oral treatment approved for relapsing forms of MS that blocks the activity of B-cells and T-cells, another type of immune cell involved in MS.
The trials enrolled 1,882 patients with relapsing MS, the majority of whom (94%) had RRMS. Findings showed that Kesimpta outperformed Aubagio in both trials, significantly reducing patients’ annual relapse rate by more than 50% and lowering their relative risk of disability progression after three months by more than 30%.
Kesimpta also was associated with fewer brain lesions on MRI scans, indicating that those taking this therapy had less extensive brain damage. Moreover, nearly nine of 10 Kesimpta-treated patients continued to show no evidence of disease activity in their second year of treatment.
“Ofatumumab demonstrates our commitment to reimagining medicine and we will work closely with all U.K. stakeholders to ensure eligible patients can start benefitting from this treatment as quickly as possible,” said Chinmay Bhatt, managing director for the U.K., Ireland & Nordics for Novartis.
The company noted that Kesimpta’s at-home administration gives patients greater flexibility and reduces the care burden on them, healthcare professionals, and the NHS.
“The self-administration of ofatumumab benefits both the clinical community and eligible patient community,” said Owen Pearson, MD, a consultant neurologist at Morriston Hospital, Swansea.
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