FDA and EMA Accept Biologics Application for Novartis Multiple Sclerosis Cell Therapy

February 27, 2020
Pharmaceutical Technology Editors

If approved, the therapy may become the first-choice treatment for relapsing multiple sclerosis patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen.

Novartis announced on Feb. 24, 2020, that FDA and the European Medicines Agency (EMA) accepted its supplemental biologics license application and marketing authorization application for ofatumumab (OMB157), a novel B-cell therapy for the treatment of relapsing forms of multiple sclerosis (RMS) in adults. If approved, the therapy may become the first-choice treatment for RMS patients and will be the first B-cell therapy that can be self-administered using an autoinjector pen, according to a Novartis press release.

The acceptances are based on positive results from a Phase III trial that determined the efficacy and safety of 20 mg of monthly subcutaneous ofatumumab versus 14 mg of Sanofi’s once daily oral Aubagio (teriflunomide) for adults with RMS, the press release said. Ofatumumab showed superiority over Aubagio and reduced the annualized relapse rate by 50.5% and 58.5%. The therapy was also successful in a Phase II study to determine if it could be self-administered using an 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, in the press release. “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.”

Approval for ofatumumab is slated for June 2020 in the United States and by the second quarter of 2021 in Europe.

Source: Novartis