WOBURN, Mass. , Nov. 14, 2024 /PRNewswire/ -- Azurity Pharmaceuticals announced today that the U.
S. Food and Drug Administration (FDA) has approved Danziten TM , the first and only nilotinib with no mealtime restrictions indicated 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 (AP) resistant or intolerant to prior therapy that included imatinib. "Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna ® , but without the fasting requirements of Tasigna," said Richard Blackburn , CEO of Azurity Pharmaceuticals, Inc.
"Unlike Tasigna, the boxed warning on the Danziten label has no requirement for patients to take their medication in a fasted state, liberating CML patients from mealtime restrictions." Tasigna has established efficacy in adults with newly diagnosed Ph+ CML-CP and resistant or intolerant Ph+ CML-CP and CML-AP. 1 However, Tasigna has variable bioavailability that considerably increases when taken with food.
In a concentration dependent manner, Tasigna may significantly prolong QT interval on surface electrocardiogram (ECG) when inappropriately taken with food. As such, strict fasting with Tasigna is crucial to avoid cardiotoxicity. 2 Danziten is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowi.
