Novartis’ Kesimpta (ofatumumab) Receives the EC’s Approval for Adult Patients with Relapsing Multiple Sclerosis

March 30, 2021 Auto Bot Adult, approval, EC, Novartis, patients, receives, regulatory 0

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

Click here to­ read full press release/ article | Ref: Novartis | Image: The Financial Express

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