The US Food and Drug Administration (FDA) has approved Azurity 色界吧s鈥� Danziten (nilotinib), the first and only nilotinib formulation that does not require mealtime restrictions, to treat chronic myeloid leukaemia (CML).
It is indicated for adults with newly diagnosed Philadelphia chromosome-positive (Ph+) CML in the chronic phase, as well as those who are resistant or intolerant to previous therapies that included imatinib.
Danziten’s reengineered formulation is said to provide equivalent efficacy to Tasigna but with enhanced bioavailability, enabling a lower dosage.
Its approval is expected to enhance patient adherence to treatment, as it eliminates the need for fasting, which has been a challenge with current therapies.
While Tasigna, the existing nilotinib treatment, has proven efficacy for Ph+ CML in chronic and acute phases, its bioavailability is affected by food intake, necessitating strict fasting to prevent cardiotoxicity.
An optimal tyrosine kinase inhibitor therapy may lead to deep molecular responses, and for some patients, even treatment-free remission, the company noted.
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By GlobalDataAzurity 色界吧s CEO Richard Blackburn said: 鈥淒anziten offers a new nilotinib treatment option with the equivalent efficacy to Tasigna, but without the fasting requirements of Tasigna.
鈥淯nlike 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.鈥�
Danziten is set to be shortly available via Biologics by McKesson and Limited Specialty Distribution.
In September this year, the FDA approved the company鈥檚 Nymalize, an oral solution provided in a 5ml prefilled ENFit syringe as an alternative for adult subarachnoid haemorrhage patients.
In 2022, it received approval for Konvomep, a treatment for active benign gastric ulcers and risk reduction of upper gastrointestinal bleeding in critically ill patients.
