The Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for ofatumumab (Novartis) for the treatment of relapsing forms of multiple sclerosis (RMS) in adults.
The sBLA is supported by data from the phase 3 ASCLEPIOS I and II trials that compared the efficacy and safety of ofatumumab, a CD20-directed cytolytic monoclonal antibody, with teriflunomide, a pyrimidine synthesis inhibitor, in 1882 adult patients with RMS. Patients were randomized to receive ofatumumab 20mg subcutaneously once monthly or oral teriflunomide 14mg once daily. The primary end point of both studies was annualized relapse rate (ARR) in patients treated for up to 30 months.
Results showed that ofatumumab significantly reduced ARR by 50.5% and 58.8% in ASCLEPIOS I and II when compared with teriflunomide (ARR=0.11 and 0.10 vs 0.22 and 0.25, P <.001), respectively. Ofatumumab also demonstrated significant suppression of both Gd+ T1 lesions and new or enlarging T2 lesions. Moreover, a relative risk reduction of 34.4% (P=.002) in 3-month confirmed disability progression (CDP) and 32.5% (P=.012) in 6-month CDP were observed in ofatumumab-treated patients when compared with teriflunomide.
With regard to safety, ofatumumab demonstrated a favorable profile consistent with that seen in previous studies.
“We are very pleased that subcutaneous ofatumumab has moved closer to potential approval for patients with relapsing multiple sclerosis in both the US and in Europe. We hope that the priority review will mean that patients in the US will have access to this treatment option earlier in 2020,” said Jan van de Winkel, PhD, CEO of Genmab.
Ofatumumab is marketed under the brand name Arzerra and is currently approved for the treatment of chronic lymphocytic leukemia (CLL) via intravenous infusion.