Health Canada OKs Self-administered Kesimpta for Adults With Active RRMS

Health Canada has approved Kesimpta (ofatumumab) for the treatment of adults with relapsing-remitting multiple sclerosis (RRMS) who have active disease, as defined by clinical and imaging features.

In contrast with other B-cell-targeting therapies used in MS, patients can self-administer a precise dose of Kesimpta at home using the Sensoready autoinjector pen. This eliminates the need to travel to hospitals and specialist infusion centers and the costs involved in doing so.

“This means that there is now an option of a B-cell therapy that can be self-administered at home, allowing for flexibility and convenience, which is especially meaningful now, more than ever,” Pamela Valentine, PhD, president and CEO of the MS Society of Canada, said in a press release.

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.

“We are hopeful that this will provide increased access to effective treatments for all Canadians living with MS, no matter where they live,” she added.

In addition to the medication’s approval, the Canadian Agency for Drugs and Technologies in Health and the Institut National d’Excellence en Santé et en Services Sociaux both have recommended that public health plans reimburse Kesimpta for the treatment of adult RRMS patients with active disease.

Kesimpta consists of an antibody that binds to and eliminates B-cells, a component of the immune system active in driving the neuroinflammation characteristic of MS. It is the first and, so far, only targeted B-cell therapy that can be self-administered at home, according to Novartis, its manufacturer.

Health Canada based its decision on results from the Phase 3 clinical trials ASCLEPIOS I (NCT02792218) and ASCLEPIOS II (NCT02792231), which compared Kesimpta’s safety and efficacy to Aubagio (teriflunomide), an oral treatment for relapsing forms of MS.

The trials enrolled 1,882 patients with relapsing MS, the majority of whom (94%) had RRMS. Compared with Aubagio, Kesimpta significantly reduced patients’ annual relapse rate by more than half, and lowered their relative risk of disability progression after three months by more than 30%.

Kesimpta also was associated with fewer MRI lesions, implying less extensive brain damage among those taking it. Novartis reported that nearly nine of 10 Kesimpta-treated patients continued to show no evidence of MS activity during their second year of treatment.

Slowing disease progression and preserving neurological function are key treatment goals for RRMS and beginning effective treatments early is critical to accomplishing this.

“MS is a disease that can easily run away and produce significant impairment if not kept in check as early as possible,” said Mark Freedman, MD, professor of medicine at the University of Ottawa.

“Having a highly effective treatment option with a favorable safety profile available like Kesimpta for treating more aggressive disease up front, offers MS patients a better chance at leading a more normal life, for a longer time,” Freedman said.

Beyond Canada, the U.S. Food and Drug Administration has approved the therapy for all relapsing forms of MS — clinically isolated syndrome, RRMS, and active secondary progressive MS — and Europe’s Committee for Medicinal Products for Human Use has recommended it be made available for the same indication.

“The development and approval of Kesimpta is an important example of our commitment to supporting and meeting the needs of those who live with MS by offering a targeted treatment that can significantly improve patient outcomes and increase the convenience of self-managing the disease at home, eliminating the need to travel for treatment,” said Andrea Marazzi, Country Pharma Organization Head, Novartis Pharmaceuticals Canada.