Danziten is set to be available soon via Biologics by McKesson and Limited Specialty Distribution. Credit: Motortion Films via Shutterstock.

The US Food and Drug Administration (FDA) has approved Azurity Pharmaceuticals’ 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.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

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.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Azurity Pharmaceuticals CEO Richard Blackburn said: “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.”

Danziten is set to be shortly available via Biologics by McKesson and Limited Specialty Distribution.

In September this year, the FDA approved the company’s 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.