AstraZeneca oral diabetes treatment gets European marketing approval

AstraZeneca said on Friday that the European Medicines Agency (EMA) has recommended marketing authorisation for its Forxiga treatment for use as an oral adjunct treatment to insulin in adults with type-1 diabetes.

The pharmaceutical group said this is the first oral medicine to receive a positive recommendation from the EMA for use in type-1 diabetes as an adjunct to insulin in patients. The positive opinion is based on Phase III data from the DEPICT (Dapagliflozin Evaluation in Patients With Inadequately Controlled Type 1-Diabetes) clinical programme.

The programme consisted of two trials, with the primary efficacy endpoint at 24 weeks and a long-term extension up to 52 weeks.

Elisabeth Björk, vice president, head of Cardiovascular, Renal and Metabolism, BioPharmaceuticals, said: "People with type-1 diabetes have not seen oral treatment innovation in decades and we believe today's announcement signals an important advancement for them, as well as a broader understanding of the well-established clinical profile of Forxiga for people living with metabolic diseases."

Forxiga is also under regulatory review in the US and Japan for use as adjunct treatment to insulin in adults with T1D.

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