Genmab announced that the US Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for Arzerra (ofatumumab) to treat patients whose chronic lymphocytic leukaemia (CLL) is resistant (refractory) to previous therapies and has granted ofatumumab priority review status.
Under priority review, the FDA sets the target date for a decision from regulators at six months, rather than the standard 10 month review. If approved, ofatumumab would be the first monoclonal antibody targeted to CD20 available for this patient population. In addition, the FDA has granted ofatumumab orphan designation for the treatment of CLL. The BLA was submitted on January 30, 2009.
"We are pleased that the ofatumumab BLA has been accepted for review by the FDA and look forward to the outcome of the review process," said Lisa N Drakeman, chief executive officer of Genmab.
The acceptance of the BLA will trigger a milestone payment from GSK to Genmab of DKK 87 million (approximately $15 million). In addition, Genmab will also receive a one-time payment of $4.5 million from GSK in exchange for terminating its option to co-promote Arzerra. In December 2008, GSK and Genmab amended their initial agreement and GSK now has exclusive global commercialization rights to Arzerra for all potential indications.
Ofatumumab is a novel, investigational, fully human monoclonal antibody that targets a membrane-proximal (close to the cell surface) small loop epitope (a portion of a molecule to which an antibody binds) on the CD20 molecule of B-cells.