Xanthus' oral fludarabine NDA accepted by FDA

Massachusetts, USA-based Xanthus Pharmaceuticals, a privately-held drug development firm, says that its New Drug Application for fludarabine phosphate oral tablets has been accepted by the Food and Drug Administration. The firm licensed US rights to the product, which is intended for the treatment of relapsed B-cell chronic lymphocytic leukemia, from Germany's Schering AG, now part of Bayer Schering Pharma, in 2006 (Marketletters passim).

Richard Dean, Xanthus' chief executive, said: "currently, patients which chronic CLL undergoing fludarabine treatment in the United States receive the drug intravenously," adding that "acceptance of the NDA application is a critical step in our effort to provide these individuals with a more patient-friendly delivery option." The FDA's decision had been expected, given that the agency had previously granted the product Orphan Drug designation in the chronic CLL indication.