Genmab: CHMP Gives Positive Opinion Recommending Ofatumumab in Relapsing MS
January 29 2021 - 12:07PM
Dow Jones News
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 stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
January 29, 2021 12:52 ET (17:52 GMT)
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