Azurity Pharmaceuticals has earned FDA approval for Danziten (nilotinib), a new formulation of Novartis’ chronic myeloid leukemia (CML) blockbuster Tasigna that doesn’t require patients to take their medication on an empty stomach.
The nod is for patients with newly diagnosed Philadelphia chromosome positive CML (Ph+ CML) in chronic phase (CP) and adults with Ph+ CML in CP or acute phase who are resistant or intolerant to prior therapy that included the chemotherapy Gleevec (imatinib).
Because Tasigna has variable bioavailability that increases when taken with food, it may significantly prolong the QT interval on surface electrocardiogram when inappropriately taken with food, Azurity said. The QT interval is a measure of how long it takes for the heart to squeeze and refill with blood before it beats again. To avoid this cardiotoxicity, strict fasting with Tasigna is required.
“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,” Richard Blackburn, CEO of Massachusetts-based Azurity, said in a release.
The effectiveness of tyrosine kinase inhibitor therapy is such that some patients can achieve remission of their cancer. Newly diagnosed CP-CML patients who respond to treatment have a life expectancy approaching that of the general populace, Azurity added. With its removal of fasting requirements, Danziten can improve adherence to the therapy
Additionally, while reformulated Danziten offers equivalent efficacy to Tasigna, its improved bioavailability allows it to be as potent at a lower dose, the company said. The therapy will be available in the “coming weeks,” Azurity added.
Tasigna, which was approved in 2007, reached blockbuster status in 2012, with sales peaking at roughly $1.9 billion from 2019 through 2023. In the first three quarters of this year, it has generated sales of $1.26 billion, which was down 10% year over year.
While Tasigna’s patent protection remains intact into 2026, there are generic versions of the treatment available in some countries overseas through Novartis’ agreement with the United Nations-backed Medicines Patent Pool. Last year, four generic drug makers signed on to provide the Tasigna knockoffs to 44 countries.
As for Azurity, it specializes in reformulating medicines for a wide range of medical conditions. In 2022, for example, it won an FDA endorsement for Zonisade, a liquid form of an epilepsy drug for those who have difficulty taking tablets. Also in 2022, the FDA signed off on Azurity’s Fleqsuvy, a grape-flavored version of the muscle relaxant baclofen for multiple sclerosis patients.
In 2019, when CutisPharma acquired Silvergate Pharmaceuticals, the company was renamed Azurity. Cutis was established in 1998.