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news.Denmark-based biotechnology company Genmab has announced that the European Medicines Agency has confirmed that the marketing authorization application for Arzerra for the treatment of chronic lymphocytic leukemia is valid and that the review procedure started on February 25, 2009.
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If approved, Arzerra (ofatumumab) would be indicated for the treatment of patients with chronic lymphocytic leukemia who have previously failed, or are inappropriate for, standard therapies. The marketing authorization application (MAA) was submitted on February 5, 2009.
The acceptance of the MAA will trigger a milestone payment from GlaxoSmithKline to Genmab of approximately $10 million.
Lisa Drakeman, CEO of Genmab, said: “We are excited to reach this important milestone so soon after submitting the Arzerra MAA to the European regulatory authorities.”