Xanthus receives orphan drug designation for oral fludarabine

The FDA grants orphan designation to products that are intended to address diseases affecting fewer than 200,000 persons in the US. If oral fludarabine receives FDA approval, this designation will entitle Xanthus to exclusive marketing rights for oral fludarabine for the treatment of chronic lymphocytic leukemia (CLL) for seven years following the NDA approval, except in limited circumstances.

Richard Dean, CEO of Xanthus, said: “We are pleased to receive orphan drug designation for oral fludarabine. With the convenience of oral dosing and a strong body of clinical efficacy and tolerability data already behind it, we believe oral fludarabine represents an exciting opportunity for Xanthus.”