Novartis and Genmab submit variation to EMA Marketing Authorization for Arzerra

Swiss drug major Novartis (NOVN: VX) has submitted a variation to the Marketing Authorization with the European Medicines Agency for the use of Arzerra (ofatumumab) as a maintenance therapy for patients with relapsed chronic lymphocytic leukemia.

This submission has been made in conjunction with its Arzerra partner, Danish drugmaker Genmab (OMX: GEN), and the application is based on interim results from a Phase III study, PROLONG. This evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for chronic lymphocytic leukemia.

Jan van de Winkel, chief executive of Genmab, said: “The PROLONG study showed the potential of using ofatumumab as an ongoing maintenance therapy for patients with relapsed CLL. We are pleased that Novartis has taken the next step with ofatumumab in this setting by submitting a regulatory application to the EMA.”