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FDA Approves Azurity's Danziten (Nilotinib) for CML Without Mealtime Restrictions

• The FDA has approved Azurity Pharmaceuticals' Danziten (nilotinib) as the first nilotinib formulation for chronic myeloid leukemia (CML) without mealtime restrictions. • Danziten is indicated for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in the chronic phase and those resistant or intolerant to prior imatinib therapies. • The reengineered formulation of Danziten offers equivalent efficacy to Tasigna but with enhanced bioavailability, enabling a lower dosage and potentially improving patient adherence. • Danziten is expected to be available soon through Biologics by McKesson and Limited Specialty Distribution, offering a more convenient treatment option for CML patients.

The U.S. Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals' Danziten (nilotinib) for the treatment of chronic myeloid leukemia (CML). This approval marks a significant advancement in CML therapy, as Danziten is the first and only nilotinib formulation that does not require mealtime restrictions, potentially improving patient adherence and quality of life.
Danziten is indicated for adult patients with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in the chronic phase, as well as those who have developed resistance or intolerance to previous treatments, including imatinib. The drug's approval addresses a critical need for CML patients who struggle with the strict fasting requirements associated with existing nilotinib treatments like Tasigna.

Enhanced Bioavailability and Patient Adherence

Danziten features a reengineered formulation designed to provide equivalent efficacy to Tasigna but with enhanced bioavailability. This improvement allows for a lower dosage while maintaining therapeutic effectiveness. According to Azurity Pharmaceuticals, the elimination of fasting requirements is expected to significantly enhance patient adherence to treatment, a known challenge with current therapies.
Richard Blackburn, CEO of Azurity Pharmaceuticals, stated, "Danziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna. 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."

Clinical Significance and Availability

Tasigna, the existing nilotinib treatment, has demonstrated efficacy for Ph+ CML in both chronic and acute phases. However, its bioavailability is significantly affected by food intake, necessitating strict fasting to prevent cardiotoxicity. Danziten's formulation mitigates this issue, offering a more convenient and potentially safer treatment option.
The company noted that optimal tyrosine kinase inhibitor therapy may lead to deep molecular responses and, in some patients, even treatment-free remission. Danziten is poised to contribute to these outcomes by improving treatment adherence and simplifying the patient experience.
Danziten is expected to be available shortly through Biologics by McKesson and Limited Specialty Distribution, ensuring timely access for patients in need.
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Reference News

[1]
FDA approves Azurity Pharmaceuticals' Danziten for CML treatment
pharmaceutical-technology.com · Nov 15, 2024

FDA approves Azurity Pharmaceuticals’ Danziten (nilotinib), the first nilotinib formulation without mealtime restriction...

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