New Boehringer and Lilly type 2 diabetes treatment gets FDA nod
pharmafile | August 28, 2015 | News story | Research and Development, Sales and Marketing | Boehringer Ingelheim, Eli Lilly, FDA, Synjardy, type 2 diabetes
The FDA has approved Synjardy, from Boehringer Ingelheim and Eli Lilly, for the treatment of adults with type 2 diabetes.
Synjardy (empagliflozin and metformin hydrochloride) is the third product containing empagliflozin to be approved by the FDA, following Jardiance (empagliflozin) and Glyxambi (empagliflozin/linagliptin).
The newly-approved drug is a combination of empagliflozin and metformin: two medicines with complementary mechanisms of action which help control blood glucose in people with type 2 diabetes (T2D).
Empagliflozin removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.
Synjardy 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. It is not indicated for treatment of type 1 diabetes.
The Synjardy label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with Synjardy.
The FDA approved Synjardy based on results from multiple clinical trials examining empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with T2D.
Synjardy was approved by the EMA in May 2015, and is the latest product to come from the formal collaboration between Boehringer and Lilly on the development and commercialisation of a portfolio of diabetes compounds, which began in January 2011.
Paul Fonteyne, president and chief executive of Boehringer Ingelheim, says: “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.”
Joel Levy
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