FDA Okays Synjardy, New Combo Medication for Type 2 Diabetes

Miriam E. Tucker


August 27, 2015

The US Food and Drug Administration (FDA) has approved a new type 2 diabetes drug that combines the sodium glucose cotransporter 2 (SGLT2) inhibitor empagliflozin with metformin hydrochloride (Synjardy, Boehringer Ingelheim and Eli Lilly), according to a news release from the two companies.

The FDA nod follows the product's licensure by the European Medicines Agency in May 2015.

In the US, the new combination is the third containing empagliflozin — the other two are the monotherapy (Jardiance, Boehringer Ingelheim) and a combination with the dipeptidyl peptidase-4 inhibitor linagliptin (Glyxambi, Boehringer Ingelheim). It's also the third SGLT2 inhibitor/metformin combination on the US market, joining dapagliflozin/metformin extended-release (Xigduo XR, AstraZeneca) and canagliflozin/metformin (Invokamet, Johnson & Johnson).

Empagliflozin/metformin hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled with either empagliflozin or metformin monotherapies, or in patients already being treated with empagliflozin and metformin. It is not indicated for the treatment of type 1 diabetes or diabetic ketoacidosis.

As with all metformin-containing products, the label contains a boxed warning for the risk for lactic acidosis. The FDA approval of the combination is based on results from multiple clinical trials of empagliflozin/metformin alone or in combination with sulfonylurea.

In May 2015, the FDA issued a warning that SGLT2 inhibitor-containing products used to treat type 2 diabetes may lead to ketoacidosis requiring hospitalization.


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