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news.Boehringer Ingelheim Pharmaceuticals (BIPI) and Eli Lilly and Company have received approval from the US Food and Drug Administration (FDA) for their Synjardy (empagliflozin and metformin hydrochloride) tablets to treat adults with type 2 diabetes (T2D).
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Earlier, the FDA has approved Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin), while Synjardy is the third product containing empagliflozin that received approval from the agency.
Both empagliflozin and metformin medicines have complementary mechanisms of action to help control blood glucose in people with T2D.
Empagliflozin is a sodium glucose co-transporter-2 (SGLT2) inhibitor that removes excess glucose through the urine by blocking glucose re-absorption in the kidney while metformin is a commonly prescribed initial treatment for T2D that lowers glucose production by the liver and its absorption in the intestine.
BIPI president and CEO Paul Fonteyne said: "Synjardy is now the fifth FDA-approved medicine to emerge from the BI-Lilly Diabetes alliance pipeline in the last four years.
"No two people with diabetes are alike, and every experience is different. Our alliance is proud to offer a diverse portfolio of treatments that can help patients throughout their diabetes journey."
The approval of Synjardy was based on multiple clinical trials showing reductions in blood glucose versus placebo.
The drug is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with empagliflozin and metformin.
According to the companies, Synjardy is not indicated to treat type 1 diabetes or diabetic ketoacidosis.
Earlier in May, Synjardy was also approved by the European Medicines Agency (EMA).