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FDA Wants More Data on Saxagliptin Dapagliflozin Combo Diabetes Medication

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Washington, DC: A new diabetes medication that combines two existing AstraZeneca drugs, Saxagliptin and dapagliflozin, has been denied approval by the Food and Drug Administration. The agency has asked AZ for more data which may warrant new clinical trials.

Had the combination treatment been approved, it would have been competed directly with Glyxambi from Lilly.

According to a company statement, data from a late-stage clinical trial showed the AstraZeneca combination therapy helped reduce blood sugar levels more than either drug taken alone. In both cases the treatments were combined with metformin, an inexpensive generic drug typically given as the first step in treating diabetes.

Saxagliptin, marketed under the brand name Onglyza, is part of a class of drugs called DPP-4 inhibitors. The treatments help the body make more insulin, which helps remove sugar from the blood. Dapagliflozin, sold as Farxiga, Xigduo XR in the US, is an SGLT-2 inhibitor, a type of drug that blocks sugar from being absorbed into the kidneys. Instead excess sugar is excreted through the urine, helping control diabetes.

In March 2014, the FDA requested clinical trial data from the AZ on saxagliptin to investigate a possible association between use of the type 2 diabetes drug and heart failure.

The request resulted from a study published in the New England Journal of Medicine (NEJM), which reported an increased rate of hospitalization for heart failure, when the heart does not pump blood well enough, with use of saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to an inactive treatment. The study did not find increased rates of death or other major cardiovascular risks, including heart attack or stroke, in patients who received saxagliptin.

In September of this year, the FDA issued a statement noting it is continuing to evaluate the risk of bone fractures with drugs in the SGLT2 inhibitor class, including dapagliflozin and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed.

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