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Update on Genmab’s ofatumumab development


Genmab A/S has announced an update on development plans for ofatumumab in autoimmune indications focusing on relapsing multiple sclerosis following the transfer of the rights to ofatumumab in this disease area from GlaxoSmithKline (GSK) to Novartis at the end of 2015.

Phase III studies are expected to be initiated by Novartis with the subcutaneous formulation of ofatumumab as therapy for patients with relapsing multiple sclerosis during the second half of 2016.

The Phase III study of the subcutaneous formulation of ofatumumab in pemphigus vulgaris, which was started by GSK will be discontinued to focus on relapsing multiple sclerosis.  The decision to discontinue the trial was not related to any safety or tolerability concerns. There are no current plans to develop ofatumumab in neuromyelitis optica.

“We are very pleased with Novartis’ commitment to move the development of ofatumumab forward in multiple sclerosis and look forward to the initiation of the Phase III studies in the second half of this year,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.