FDA Finally Okays Dapagliflozin/Saxagliptin for Type 2 Diabetes

February 28, 2017

The US Food and Drug Administration (FDA) has approved a once-daily oral fixed-dose medication, called Qtern, combining 5 mg of the DPP-4 inhibitor saxagliptin (Onglyza, AstraZeneca) and 10 mg of the SGLT2 inhibitor dapagliflozin (Forxiga/Farxiga, AstraZeneca) for the treatment of type 2 diabetes in adults, according to a news release from AstraZeneca.

Qtern is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type-2 diabetes who have inadequate control with dapagliflozin (10 mg) or who are already treated with dapagliflozin and saxagliptin.

The FDA had earlier rejected approval of Qtern at the end of 2015, stating that more clinical data were required before it could approve the combination.

The US agency did, however, approve a combination of the DPP-4 inhibitor linagliptin (Tradjenta) and SGLT2 inhibitor empagliflozin (Jardiance), known as Glyxambi, developed by Boehringer Ingelheim/Eli Lilly in February 2015.

And the European Medicines Agency recommended Qtern for approval for use in adults with type 2 diabetes in May 2016.

SGLT2 inhibitors help patients achieve improved glycemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine; in trials, they have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-4 inhibitors reduce blood glucose as measured by HbA1c.

Both drug classes, however, have also been associated with undesirable side effects.

Most recently, a European Medicines Agency (EMA) panel said a warning stating that the SGLT2 inhibitors may increase the risk for lower-limb amputation should be included in the prescribing information for all drugs in this class.

And last June the FDA strengthened warnings for dapagliflozin, along with another SGLT2 inhibitor, canagliflozin (Invokana, Janssen) related to acute kidney injury. SGLT2 inhibitors have also rarely been linked with diabetic ketoacidosis, said to affect one in 1000 patients — the EMA has updated the labels of such products to indicate this risk, as has the FDA. And drugs in this class are also known to increase the risk of genital mycotic infections.

And saxagliptin has a warning on the US label cautioning that it may increase the risk for heart failure, particularly in patients who already have cardiovascular or kidney disease, based on findings from the Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus–Thrombolysis in Myocardial Infarction 53 (SAVOR-TIMI 53).

Follow Lisa Nainggolan on Twitter: @lisanainggolan1 . For more diabetes and endocrinology news, follow us on Twitter and on Facebook .

 

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