FDA extends review of Novartis' ofatumumab filing in relapsing MS

Novartis and partner Genmab announced Tuesday that the FDA has prolonged its review of the self-administered, targeted B-cell therapy ofatumumab for patients with relapsing multiple sclerosis (RMS), with a regulatory decision now due in September. Regulators in the US and Europe had accepted Novartis' filings for ofatumumab in this indication back in February.

The submissions were based on results from the Phase III ASCLEPIOS I and II studies, which evaluated the efficacy of monthly subcutaneous ofatumumab versus once-daily treatment with Sanofi's oral drug Aubagio (teriflunomide) in adults with RMS. Ofatumumab demonstrated superiority over Aubagio in both trials.

'Ready to launch' upon approval

Marie-France Tschudin, president of Novartis Pharmaceuticals, said the drugmaker would "continue to work with the FDA to complete the review as soon as possible. We are well prepared and ready to launch ofatumumab upon approval." Meanwhile, Novartis noted that regulatory approval for ofatumumab in Europe is expected by the second quarter of 2021.

Ofatumumab is already cleared in the US and EU as a first-line treatment for chronic lymphocytic leukaemia (CLL) under the name Arzerra. It was later approved by the FDA and regulators in Europe for patients with relapsed CLL.

The anti-CD20 monoclonal antibody, also known as OMB157, was originally co-developed by GlaxoSmithKline and Genmab, with GlaxoSmithKline eventually selling all rights to the drug to Novartis in 2015.

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