Novartis’ ofatumumab outclasses Sanofi’s Aubagio at Phase 3 in relapsing multiple sclerosis
New data from two Phase 3 studies have indicated that Novartis’ ofatumumab outperformed Sanofi Genzyme’s Aubagio (teriflunomide) in the treatment of relapsing forms of multiple sclerosis (RMS).
The trials, spanning 350 sites across 37 countries and comprising 1,882 patients between 18 and 55, revealed that the monthly subcutaneous 20mg formulation of ofatumumab met its primary endpoint to reduce the annualised relapse rate (ARR) compared to the daily oral 14mg Aubagio therapy, showing a “highly significant and clinically meaningful reduction in the number of confirmed relapses”.
Ofatumumab also met its secondary endpoints, effectively delaying time to confirmed disability progression in patients.
“This data signifies a possible turning point for ofatumumab and provides support for our belief that it has the potential, if approved, to become the first subcutaneous B-cell therapy for relapsing MS that can be self-administered by patients at home,” remarked Dr Jan van de Winkel, Chief Executive Officer of Genmab. “We look forward to feedback from regulatory authorities and to this exciting next phase in ofatumumab’s development.”
Novartis confirmed its plans to submit these data in support of regulatory applications by the end of this year.
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