Azurity Pharmaceuticals has received FDA approval for Danziten (nilotinib), a novel formulation indicated for adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). This includes newly diagnosed patients in the chronic phase, as well as those with chronic or acute phase CML resistant or intolerant to prior therapies, including imatinib. The key advantage of Danziten is that it does not require fasting, unlike the original nilotinib formulation, Tasigna.
Overcoming Mealtime Restrictions
Tasigna, while effective, has specific fasting requirements due to variable bioavailability that increases significantly when taken with food. This can lead to QT interval prolongation and potential cardiotoxicity if not taken in a fasted state. Richard Blackburn, CEO of Azurity Pharmaceuticals, stated that Danziten offers equivalent efficacy to Tasigna but without the fasting requirements, liberating CML patients from mealtime restrictions.
Improved Bioavailability and Adherence
Danziten is re-engineered to provide consistent pharmacokinetics, eliminating clinically significant differences in nilotinib exposure regardless of fasting state or meal type. This improved bioavailability allows for a lower dose while maintaining the proven efficacy of nilotinib. Optimal tyrosine kinase inhibitor (TKI) therapy can lead to deep molecular responses and potentially treatment-free remission, with life expectancy for responding CP-CML patients approaching that of the general population. By removing fasting requirements, Danziten has the potential to improve patient adherence to treatment.
Availability and Patient Support
Danziten will be available in the coming weeks through Biologics by McKesson and Limited Specialty Distribution. Azurity will offer patient support through DanzitenCONNECT, a comprehensive program that includes Prior Authorization support and Benefits Investigation, a free first month of Danziten, a co-pay program, and a Patient Assistance Program (PAP).
