AstraZeneca Combo for Type 2 Diabetes Gets Green Light in EU

Disclosures

May 27, 2016

The European Medicines Agency (EMA) has given the green light to a fixed-dose combination of saxagliptin (Onglyza, AstraZeneca) and dapagliflozin (Forxiga/Farxiga, AstraZeneca), two oral blood glucose-lowering medicines, for the treatment of type 2 diabetes in adults.

The product, to be known as Qtern, is a combination of the dipeptidyl peptidase 4 (DPP-4) inhibitor saxagliptin and the sodium-glucose cotransporter 2 (SGLT2) inhibitor dapagliflozin and was given a positive opinion by the EMA's Committee for Medicinal Products for Human Use (CHMP).

This same combination was rejected by the Food and Drug Administration (FDA) at the end of last year; the US agency said that more clinical data were required before it could approve the combination of saxagliptin and dapagliflozin. The FDA has, however, approved a combination of the DPP-4 inhibitor linagliptin (Tradjenta) and SGLT2 inhibitor empagliflozin (Jardiance), known as Glyxambi, and developed by Boehringer Ingelheim/Eli Lilly.

Qtern: First DPP-4 Inhibitor/SGLT2 Inhibitor Combo in EU

If approved in the European Union, which is usually a formality within a couple of months, Qtern will be the first DPP-4–inhibitor/SGLT2-inhibitor combination product approved in Europe. It will be available as film-coated tablets (containing 5-mg saxagliptin and 1- mg dapagliflozin) and the full indication will be:

  • To improve glycemic control when metformin and/or sulfonylurea and one of the monocomponents of Qtern do not provide adequate glycemic control.

  • For patients already being treated with the free combination of dapagliflozin and saxagliptin.

AstraZeneca notes that the EU submission for Qtern included data from three studies in type 2 diabetes and that, in these trials, the safety profile of the combination was similar to the known safety profiles of saxagliptin and dapagliflozin.

Follow Lisa Nainggolan on Twitter: @lnainggolan1. For more diabetes and endocrinology news, follow us on Twitter and on Facebook .

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