(RTTNews) - Novartis said that Phase III ASCLEPIOS trials demonstrated superior efficacy of ofatumumab in patients with relapsing multiple sclerosis.
ASCLEPIOS I and II studies evaluated the safety and efficacy of ofatumumab 20 mg monthly subcutaneous injections versus teriflunomide 14 mg oral tablets taken once daily in adults with relapsing forms of multiple sclerosis or 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 or ARR.
The US Food and Drug Administration and European Medicines Agency are currently reviewing ofatumumab for the treatment of relapsing forms of multiple sclerosis in adult.
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, the company said.