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AZ's diabetes drug Forxiga secures EU approval for adjunctive use in type 1 patients

Published on 25/03/19 at 10:09am

AstraZeneca has revealed that its sodium-glucose co-transporter 2 (SGLT2) inhibitor Forxiga (dapagliflozin) has secured approval from the European Commission for the treatment of type 1 diabetes – the first approval for the drug in the condition, specifically in patients with a BMI ≥ 27 kg/m2 and where insulin alone does not provide adequate glycaemic control despite optimal insulin therapy.

Phase 3 data submitted in support of the decision illustrated that, in this indication, a 5mg dose of Forxiga “demonstrated significant and clinically-meaningful reductions from baseline in average blood glucose levels HbA1c (primary endpoint), weight and total daily insulin dose (secondary endpoints) at 24 and 52 weeks.”

The drug’s safety profile in type 1 diabetes was found to be consistent with its profile in type 2 forms of the condition, though a higher prevalence of diabetic keratinosis events were observed.

“Forxiga is the first oral medicine approved in Europe as an adjunct to insulin for people living with type-1 diabetes whose glucose levels are not adequately controlled with insulin alone. We look forward to bringing Forxiga to a patient population that has not had any approved oral medicines available before,” commented Elisabeth Björk, Senior Vice President, Head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals.

AstraZeneca is also currently awaiting regulatory decisions in Japan and the US in the adjunctive treatment of type 1 diabetes patients, with rulings expected in the first and second halves of this year, respectively.  

Matt Fellows

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