US-based Azurity Pharmaceuticals has received the US Food and Drug Administration (FDA) approval for Danziten (nilotinib) to treat a type of myeloid leukaemia.
Danziten is a re-engineered formulation of nilotinib, an anti-cancer medication sold by Swiss drugmaker Novartis, under the brand name Tasigna.
The drug is indicated for adults with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) with chronic phase (CP) and acute phase (AP) resistant prior therapy.
Azurity Pharma said that its new formulation will provide equivalent efficacy to Tasigna, with improved bioavailability, and allows for a lower dose.
Danziten showed consistent pharmacokinetics, with no clinically significant differences in nilotinib exposure regardless of fasting state or meal type, said the US drugmaker.
Azurity Pharma plans to commercialise Danziten in the coming weeks, through speciality pharmacy company Biologics by McKesson and Limited Specialty Distribution.
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.”
According to the company, the life expectancy of newly diagnosed CP-CML patients is reaching that of the general population, with patient adherence challenges still persistent.
Danziten is an optimal tyrosine kinase inhibitor (TKI) therapy that helps patients achieve deep molecular responses and treatment-free remission in some.
It is the first and only nilotinib with no mealtime restrictions and can improve adherence due to the removal of fasting requirements, said Azurity.
Furthermore, the company will offer Danziten CONNECT, a patient support programme that includes prior authorisation support and benefits investigation free of cost for the first month.
