Azurity Pharmaceuticals has won U.S. FDA approval for a re-engineered formulation of nilotinib, branded Danziten, for adults with chronic myeloid leukemia.
Danziten is approved for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase and adult patients with chronic phase (CP) and acute phase resistant or intolerant to prior therapy that included imatinib.
Danziten is a re-engineered formulation of Novartis' Tasigna, approved in 2007, but with an important distinction — no mealtime restrictions. Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state. The tyrosine kinase inhibitor therapy offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose.
Massachusetts-based Azurity plans to make Danziten available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution.