Qtern Receives Green Light from FDA

Pharmaceutical giant AstraZeneca has just announced that its newest type 2 diabetes medication, Qtern, has received FDA approval. Qtern is taken orally once daily, and is indicated for use by adults with type 2 diabetes, along with diet and exercise. The medication is made up of 5 mg of a DPP-4 inhibitor, saxagliptin (Onglyza) and 10 mg of a SGLT-2 inhibitor, dapagliflozin (Forxiga/Farxiga), both manufactured by AstraZeneca.

Each of these components are anti-hyperglycemic in nature, and work via complementary mechanisms. DPP-4 inhibitors are known for reducing blood glucose by way of HbA1c levels. SGLT-2 inhibitors also lower HbA1c levels, and have been shown to reduce weight and blood pressure by increasing the amount of glucose excreted by the body and decreasing the amount recycled back into the body.

Qtern was originally not approved by the FDA when it was reviewed at the end of 2015, due to lack of clinical data indicating its safety and efficacy. Since then however, several clinical trials have been conducted, including a 24-week, multi-center, placebo-controlled, randomized, and double-blind Phase III study. Other studies centered around the long term use of the combination medication and strengthened the data proving Qtern’s safety. The results from these studies were enough for the FDA to give AstraZeneca the approval. Conversely, the European Medicines Agency recommended Qtern for use in May 2016.

Side effects

However, both SGLT-2 inhibitors and DPP-4 inhibitors can come with undesirable side effects that users should be aware of. SGLT-2 inhibitors are known to increase the risk of lower limb amputations. They have also been linked to acute kidney injury, genital mycotic infections, and rarely can be associated with diabetic ketoacidosis. DPP-4 inhibitors, including saxagliptin, are generally accompanied by a boxed warning indicating that they may increase the risk for heart failure, especially in individuals who have a history of cardiovascular or kidney problems.

A similar drug has been on the market since February of 2015, that is a combination of a DPP-4 inhibitor and a SGLT-2 inhibitor. The medication is called Glyxambi, and is manufactured by Boehringer Ingelheim/Eli Lilly.

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