The European Commission (EC) has approved a new type 2 diabetes called Qtern, which was rejected last year in the US.
Combination drugs such as Qtern have benefits in that they provide more than one treatment in a single pill, which can make it easier for patients to manage and remember their medication.
The EC based its approval for Qtern following the success of three trials that paired the combination drug with metformin. Two trials showed the AstraZeneca drug outperformed placebo at reducing HbA1c, and the third showed Qtern was statistically superior in lowering HbA1c compared to saxagliptin or dapagliflozin alone when added to metformin.
In these trials, the safety profile of Qtern was found to be similar to those of saxagliptin and dapagliflozin.
Qtern is indicated for adults with type 2 diabetes aged 18 years and older who do not have adequate blood sugar control from metformin and/or sulphonylurea and an SGLT2 inhibitor or DDP-4 inhibitor. Patients could also be treated with Qtern if they are already taking a free combination of saxagliptin and dapagliflozin.
AstraZeneca has previously tried to get approval from the US Food and Drug Administration (FDA), but they were told in October that additional clinical data would be required.
While Qtern is the first drug combination of its kind to be approved in Europe, Eli Lilly and Boehringer Ingelheim’s drug Glyxambi, which combines linagliptin and empagliflozin, debuted in the US last year. Currently, though, Glyxambi has not yet been made available in Europe.
Qtern will require approval by UK regulatory agencies before it becomes available in the UK.