Shots:

• The approval is based on P-III ASCLEPIOS I and II studies that involve assessing Kesimpta (20mg- monthly- SC) vs teriflunomide (14mg- PO- qd) in 1-882 adults aged 18-55yrs. with a confirmed diagnosis of RMS
• The study demonstrated a reduction of annual relapses by over 50% and achieved >30% relative risk reduction of 3mos. confirmed disability progression
• The EC’s approval follows EMA’s CHMP positive opinion in Jan’2021. Kesimpta is the first and only self-administered- targeted B-cell therapy for adult patients with RMS approved in the EU

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