Novartis has revealed that both the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted its Supplemental Biologics License Application (sBLA) and Marketing Authorisation Application (MAA), for ofatumumab - formerly known as OMB157.
The fully human anti-CD20 monoclonal antibody, indicated for the treatment of relapsing forms of multiple sclerosis (RMS) in adults, is a novel B-cell therapy that delivers sustained efficacy with a favourable safety profile.
If approved, the company says that ofatumumab has the potential to become a first-choice treatment for a broad RMS population, as it would be the first easy-to-start B-cell therapy. It is also manageable in a monthly subcutaneous injection that can be self-administered at home using an autoinjector pen, making adherence easier.
On the news, Novartis says that regulatory approval for ofatumumab in the US is expected in June 2020 and in Europe by the second quarter of 2021, based on positive data from the Phase III ASCLEPIOS I and II studies.
In both head-to-head studies, ofatumumab demonstrated superiority over Aubagio in patients with RMS, showing a highly significant and clinically meaningful reduction in the number of confirmed relapses.
Novartis says that it is “excited” that ofatumumab has the potential to be a “powerful first-choice treatment option for patients and physicians looking for an impactful intervention,” according to Krishnan Ramanathan, neuroscience global program head at Novartis.
“With ofatumumab, we underpin our relentless dedication to reimagine 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.”
MS, which affects approximately 2.3 million people worldwide, disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss. Further to this, approximately 85% of patients initially present with relapsing forms of MS.