Novartis announces FDA and EMA filing acceptance of ofatumumab, for treatment of relapsing form of MS

Basel: Novartis have announced that both the US Food and Drug Administration (FDA) and European Medicines Agency (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 adults.

Ofatumumab is a novel B-cell therapy that delivers sustained efficacy with a favourable safety profile. If approved, ofatumumab has the potential to become a first-choice treatment for a broad RMS population and the first B-cell therapy that is 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 positive data from the Phase III ASCLEPIOS I and II studies, which investigated the efficacy and safety of monthly subcutaneous ofatumumab 20mg versus once-daily oral Aubagio®* (teriflunomide) 14mg in adults with RMS. In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio® in patients with RMS. Both studies met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR). Key secondary endpoints of delaying time to confirmed disability progression(CDP) were also met1. Data presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) showed that compared to Aubagio®, ofatumumab:

Overall ofatumumab, a potent, fully-human antibody targeting CD20 positive B-cells, delivered efficacy with a favourable safety profile. The safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from Phase II results.

In addition, Novartis has completed the APLIOS study, an open-label Phase II study, 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 RMS5. The positive results of the study will be presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in Florida, US. These results show that ofatumumab offers a highly effective B-cell therapy that can be self-administered at home using a patient-friendly autoinjector pen.

"We are excited that ofatumumab has the potential to be a powerful first-choice treatment option for patients and physicians looking for an impactful intervention," said Krishnan Ramanathan, Neuroscience Global Program Head at Novartis.

"With ofatumumab, we underpin our relentless dedication to reimagining medicine for patients across the MS spectrum and will work closely with the regulatory authorities to ensure it is available for people living with MS as soon as possible."

Regulatory approval for ofatumumab in the US is expected in June 2020 and in Europe by Q2 2021. Novartis is committed to bringing ofatumumab to patients worldwide and additional regulatory filings are currently underway.

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