Feb 24, 2020: Novartis announced that both the USFDA and 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 the adults.
Ofatumumab is a novel B-cell therapy that delivers sustained efficiency with a favorable safety profile.
If approved, ofatumumab has the prospective to become a first-choice treatment for the broad RMS population and the first B-cell therapy that can be 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 the positive data from Phase III ASCLEPIOS I and II studies, which investigated the effectiveness and safety of monthly subcutaneous ofatumumab 20mg against once daily oral Aubagio®* (teriflunomide) 14mg in adults with RMS. In both head-to-head studies, ofatumumab demonstrated dominance over Aubagio® in patients with RMS
All research reached the primary endpoints where ofatumumab demonstrated a highly significant and clinically meaningful decrease in the number of reported relapses, measured as the annualized relapse rate (ARR). Key secondary delay time endpoints for confirmed progression of disability (CDP) were also met. Data presented at the 35th Congress of the European Committee for Multiple Sclerosis Treatment and Research (ECTRIMS) showed that ofatumumab reduced ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs. 0.25) (p<0.001 in both studies) respectively in ASCLEPIOS I and II compared with Aubagio ®. Showed highly important suppression of both Gd+ T1 lesions and new or enlarging T2 lesions, demonstrating a profound abrogation of new inflammatory activity. Showed a relative risk reduction of 34.4% in three-month CDP and 32.5% in six-month CDP in pre-specified pooled analyses
In general ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered efficacy with a favorable safety profile. The safety profile of the ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results.
Additionally, Novartis has completed the APLIOS study, an open-label Phase II study which is to determine the bioequivalence of subcutaneous administration of ofatumumab via a pre-filled syringe – as used in ASCLEPIOS I and II – and an autoinjector pen in patients with RMS. The positive results of the study will be presented at the Americas Committee for Treatment and Research in the Multiple Sclerosis (ACTRIMS) Forum in Florida, US. These results show that ofatumumab offers a highly efficient B-cell therapy that can be self-administered at home using a patient-friendly autoinjector pen.
Regulatory approval for the ofatumumab in US is expected in June 2020 and in Europe by Q2 2021. Novartis is committed to bringing ofatumumab to the patients worldwide and additional regulatory filings are currently underway.
https://www.novartis.com/news/media-releases/novartis-announces-fda-and-ema-filing-acceptance-ofatumumab-novel-b-cell-therapy-patients-relapsing-forms-multiple-sclerosis-rms
