FDA Approves Azurity's Danziten for CML

The US Food and Drug Administration (FDA) has granted approval to Azurity Pharmaceuticals for its innovative drug, Danziten (nilotinib). This new formulation marks a significant breakthrough for the treatment of chronic myeloid leukemia (CML), as it is the first nilotinib formulation that does not impose mealtime restrictions.

Danziten is specifically indicated for adult patients who have been newly diagnosed with Philadelphia chromosome-positive (Ph+) CML in the chronic phase. Additionally, it is suitable for those who have shown resistance or intolerance to previous therapies, including imatinib.

One of the standout features of Danziten is its reengineered formulation, which ensures equivalent efficacy to the previously established drug, Tasigna. However, Danziten boasts enhanced bioavailability, which means that the same therapeutic effects can be achieved with a lower dosage. This improvement is expected to significantly boost patient adherence to their treatment regimens, as it eliminates the need for fasting—a common challenge with existing therapies.

Tasigna, the current nilotinib treatment, has proven its effectiveness for treating Ph+ CML in both chronic and acute phases. However, its bioavailability is adversely affected by food intake, thus necessitating strict fasting protocols to avoid cardiotoxicity risks. This requirement has posed a considerable inconvenience for patients, affecting their quality of life and treatment adherence.

Azurity Pharmaceuticals is confident that Danziten's improved formulation will provide a more patient-friendly option. The company highlights that an optimal tyrosine kinase inhibitor therapy can lead to profound molecular responses, and in some cases, even treatment-free remission.

Richard Blackburn, CEO of Azurity Pharmaceuticals, emphasized the benefits of Danziten, stating, “Danziten offers a new nilotinib treatment option with the same efficacy as Tasigna, but without the fasting requirements. Unlike Tasigna, the boxed warning on the Danziten label does not require patients to take their medication in a fasted state, freeing CML patients from mealtime restrictions.”

The availability of Danziten is anticipated soon through Biologics by McKesson and Limited Specialty Distribution.

This recent FDA approval builds on Azurity Pharmaceuticals’ track record of innovative treatments. In September, the FDA approved Nymalize, an oral solution provided in a 5ml prefilled ENFit syringe, as an alternative for adult patients with subarachnoid hemorrhage. Furthermore, in 2022, Azurity received approval for Konvomep, a treatment designed to manage active benign gastric ulcers and to reduce the risk of upper gastrointestinal bleeding in critically ill patients.

Danziten's approval represents a significant advancement in the treatment of chronic myeloid leukemia, offering patients a more convenient and potentially more effective therapy option. As it becomes available, it is expected to improve adherence rates and overall treatment experiences for CML patients, setting a new standard in leukemia care.