On Wednesday, Novartis unveiled new positive results for Kesimpta, its treatment for relapsing-remitting multiple sclerosis (RRMS), at the annual conference of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), which opens today in Barcelona.

Data from a Phase IIIb clinical study show that patients who switched to Kesimpta after experiencing persistent disease activity while on fingolimod or fumarate-based therapies had a significant reduction in disease activity.

Specifically, the average annual relapse rate (ARR) was very low, at 0.06 over a period of 96 weeks (approximately two years).

These results also showed a near disappearance of MRI-visible disease activity, with more than 90% of participants achieving the NEDA-3 (No Evidence of Disease Activity) criterion, characterized by no relapses, no new MRI lesions, and no disability progression.

In another trial, this time including individuals who had been recently diagnosed (less than three years ago) and had never received treatment before, more than 90% of those treated with Kesimpta from the outset maintained NEDA-3 status for a period of seven years.

Now approved in 92 countries, Kesimpta has benefited over 150,000 patients to date.

This fully human recombinant monoclonal antibody, self-administered by monthly subcutaneous injection, works by binding to distinct epitopes of the CD201 antigen, a mechanism that causes B-cell lysis (cell membrane degradation) and allows for faster B-cell reconstitution.

The drug, originally developed by Genmab and licensed to GlaxoSmithKline, was acquired by Novartis in 2015 for all its possible indications.