Genmab, Novartis leukemia drug Arzerra filed for European approval

COPENHAGEN (Reuters) – Novartis submitted an application to the European Medicines Agency (EMA) for the use of ofatumumab, branded as Arzerra, as maintenance therapy for patients with relapsed chronic lymphocytic leukemia, its co-developer Genmab said. 

    The application is based on interim results from a Phase III study. Arzerra is already approved in Europe for use in combination with other drugs for some therapies.

(This version of the July 7 story was corrected to clarify that Novartis submitted application, not Genmab.)

(Reporting by Annabella Pultz Nielsen; editing by Sabina Zawadzki)

• European Medicines Agency
• Novartis
• chronic lymphocytic leukemia