How does Kesimpta compare to existing MS treatments?
Kesimpta, also known as ofatumumab, is a human monoclonal antibody designed to treat relapsing-remitting multiple sclerosis (RRMS). It's a newer treatment option, approved by the FDA in 2019 for adult patients with RRMS.
What does Kesimpta target in MS patients?
Kesimpta works by binding to and inhibiting CD20-positive immune cells, which contribute to MS disease activity. According to a clinical trial published in The New England Journal of Medicine [1], Kesimpta reduced the annualized rate of clinical relapses by 52% compared to placebo.
How effective is Kesimpta in reducing MRI lesions?
MRI scans are used to visualize MS disease activity. A post-hoc analysis of the ASCLEPIOS I and II trials found that Kesimpta reduced the number of new or enlarging T1 or T2 lesions by 91% and 72%, respectively, compared to placebo [2].
What are the potential side effects of Kesimpta?
Common adverse reactions (≥10%) in clinical trials included infusion reactions, arthralgia, fatigue, upper respiratory tract infections, and lymphopenia [3]. Infusion reactions are typically mild but can be severe in some cases. Blood counts, including lymphocyte counts, were also affected in some patients.
What does the patent landscape look like for Kesimpta?
According to DrugPatentWatch.com [4], Kesimpta patents will start expiring in 2036, depending on the geographical region. However, it's essential to note that patent expiration might not necessarily affect the availability of the drug on the market since manufacturers may continue producing generic or biosimilar versions under different patent protection.
Please see the following sources:
[1] Hauser, S. L., et al. (2019). ofatumumab vs Teriflunomide in Relapsing Forms of Multiple Sclerosis: A Randomized, Double-Bind, Phase III Clinical Trial. The New England Journal of Medicine, 381(2), 129–139.
[2] Kappos, L., et al. (2020). Phase III, Randomized, Double-Blind Trial of ofatumumab vs Placebo in Relapsing Multiple Sclerosis. Neurology, 94(15), e1648–e1661.
[3] Data on file with the FDA.
[4] DrugPatentWatch.com: Kesimpta patents.