AstraZeneca gets first approval for drug in type 1 diabetes

AstraZeneca’s (LSE: AZN) Forxiga (dapagliflozin) has become the first oral medicine approved in Europe as an adjunct to insulin for adults with type-1 diabetes.

The Anglo-Swedish pharma major has at the same time scored its first approval in type 1 diabetes with the European Commission’s decision to green-light Forxiga as adjunct to insulin in patients with a BMI ≥ 27 kg/m2, when insulin alone does not provide adequate glycemic control despite optimal insulin therapy.

Data from the Phase III DEPICT trial formed the basis of this approval for Forxiga, which is currently under regulatory review in Japan and the USA for use as an adjunct treatment to insulin in adults with type 1 diabetes, with a decision expected in the first and second half of 2019, respectively.