FDA and EMA accept licence applications for multiple sclerosis treatment

The US Food and Drug Administration (FDA) and European Medicines Agency (EMA) have accepted Novartis’ Supplemental Biologics License Application (sBLA) and Marketing Authorisation Application (MAA), respectively, for ofatumumab 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.

The company said that data showed that compared to Aubagio, ofatumumab:

• Reduced the ARR by 50.5 percent and 58.5 percent in ASCLEPIOS I and II respectively
• Showed significant suppression of both Gd+ T1 lesions and new or enlarging T2 lesions
• Showed a relative risk reduction of 34.4 percent in three-month CDP and 32.5 percent in six-month CDP in pre-specified pooled analyses
• 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.

“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 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.”

Regulatory approval for ofatumumab in the US is expected in June 2020 and in Europe by 2021.