- Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis1
- ASCLEPIOS I and II demonstrated significant reductions in risk of relapses, confirmed disability worsening and profound reduction of active or new brain lesions1
- The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis (RMS) in adults
- If approved, ofatumumab will be the first B-cell therapy that can be self-administered at home and has the potential to become a first-choice treatment for use in RMS patients
Basel, August 5, 2020 — Novartis today announced that The New England Journal of Medicine (NEJM) published the positive results from the ASCLEPIOS I and II studies evaluating the safety and efficacy of ofatumumab (OMB157) 20 mg monthly subcutaneous injections versus teriflunomide 14 mg oral tablets taken once daily in adults with relapsing forms of multiple sclerosis (RMS). Both studies met the primary endpoints where ofatumumab showed a significant reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR)1.
“ASCLEPIOS I and II demonstrate the efficacy and safety of ofatumumab and its potential to become a first-choice treatment option that offers RMS patients the flexibility as they continue to live their lives,” said Krishnan Ramanathan, Neuroscience Global Program Head at Novartis. “Ofatumumab is a testament to our commitment to advance science and investigate potential treatments that reimagine care and address significant unmet needs at all parts of the RMS journey.”
Results from the ASCLEPIOS I and II studies showed that compared with teriflunomide, ofatumumab: