Genmab: CHMP Gives Positive Opinion Recommending Ofatumumab in Relapsing MS

By Stephen Nakrosis

Genmab A/S on Friday said the European Medicines Agency's Committee for Medicinal Products for Human Use gave a "positive opinion and recommended granting marketing authorization of subcutaneous ofatumumab for the treatment of relapsing forms of multiple sclerosis."

Ofatumumab is being "developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG", the company said.

In January 2020, Novartis submitted the Marketing Authorization Application for ofatumumab in this indication, Genmab said.

"The positive CHMP opinion for subcutaneous ofatumumab in relapsing multiple sclerosis is an important step in potentially bringing this product to patients in Europe who will benefit from the efficacy and ease of dosing that ofatumumab will provide," said Jan van de Winkel, Genmab's chief executive. "We look forward to the European Commission's final decision on this application."

Genmab said ofatumumab is self-administered by a once-monthly subcutaneous injection.

Write to Stephen Nakrosis at [e-mail]

(END) Dow Jones Newswires

January 29, 2021 12:52 ET (17:52 GMT)

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