Specialty pharmaceutical company Azurity Pharmaceuticals announced on Thursday that it has received approval from the US Food and Drug Administration (FDA) for Danziten tablets, the first and only nilotinib with no mealtime restrictions.

The treatment is indicated for adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukaemia (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 is a re-engineered formulation of nilotinib without mealtime restrictions that offers equivalent efficacy to Tasigna but with improved bioavailability, allowing for a lower dose. According to Azurity, Danziten demonstrates consistent pharmacokinetics with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type, while offering the proven efficacy expected from nilotinib.

Danziten will be available in the coming weeks.