Novartis announces FDA and EMA filing acceptance of ofatumumab, a novel B-cell therapy for patients with relapsing forms of multiple sclerosis (RMS)

• Filings are supported by Phase III ASCLEPIOS I and II studies, where ofatumumab showed highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as annualized relapse rate (ARR)¹
   
• Ofatumumab is a novel B-cell therapy that delivers sustained efficacy with a favorable safety profile¹
   
• If approved, ofatumumab has the potential to become a first-choice treatment for a broad RMS population and the first B-cell therapy that can be self-administered at home using an autoinjector pen
   
• Regulatory approval for ofatumumab in the US is expected in June 2020 and in Europe by Q2 2021

  
Basel, February 24, 2020 — Novartis today announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted the company’s Supplemental Biologics License Application (sBLA) and Marketing Authorization Application (MAA), respectively, for ofatumumab (OMB157) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. Ofatumumab is a novel B-cell therapy that delivers sustained efficacy with a favorable safety profile¹. If approved, ofatumumab has the potential to become a first-choice treatment for a broad RMS population and the first B-cell therapy that is easy to start and manage in a monthly subcutaneous injection that can be self-administered at home using an autoinjector pen.

The regulatory applications are based on positive data from the Phase III ASCLEPIOS I and II studies, which investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once daily oral Aubagio* (teriflunomide) 14mg in adults with RMS^2,3. In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio in patients with RMS¹. Both studies met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR)¹. Key secondary endpoints of delaying time to confirmed disability progression^† (CDP) were also met¹. Data presented at the 35^th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showed that compared to Aubagio, ofatumumab: