FDA Priority Review for Arzerra as maintenance therapy for relapsed CLL

20 September 2015

The US Food and Drug Administration has granted Priority Review to the supplemental Biologics License Application (sBLA) for Arzerra (ofatumumab) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL).

The application for the CD20 inhibitor was submitted to the FDA by Swiss pharma giant Novartis (NOVN: VX) under its ofatumumab collaboration with Denmark’s Genmab (OMX: GEN) in July 2015.

Rights to ofatumumab acquired by Novartis from GSK

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