FDA Approves Synjardy for Treatment of Type 2 Diabetes

Strategic Insights -

The US Food and Drug Administration has approved Synjardy, a combination medication of empagliflozin and metformin, for the treatment of adults with type 2 diabetes. This approval marks the third product containing empagliflozin to be approved by the FDA, following Jardiance and Glyxambi. Synjardy combines two medicines with complementary mechanisms of action to help control blood glucose levels in people with type 2 diabetes. The medication has a boxed warning for the risk of lactic acidosis, a serious metabolic complication.

Key Takeaways:

  • Synjardy is a combination medication of empagliflozin and metformin, approved for the treatment of adults with type 2 diabetes.
  • The medication is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes who are not adequately controlled on a regimen containing empagliflozin or metformin.
  • Synjardy is not approved for the treatment of type 1 diabetes or diabetic ketoacidosis.
  • The medication has a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with SYNJARDY.
  • Synjardy was approved based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with type 2 diabetes.
  • The medication was also recently approved by the European Medicines Agency in May 2015.
  • Synjardy is the fifth FDA-approved medicine to emerge from the BI-Lilly Diabetes alliance pipeline in the last four years.

Statistics:

  • 3: Number of products containing empagliflozin approved by the FDA, including Jardiance, Glyxambi, and Synjardy.
  • 2: Number of medicines with complementary mechanisms of action in Synjardy, empagliflozin and metformin.
  • 1 in 10: Percentage of people with type 2 diabetes who are not adequately controlled on current regimens (Source: American Diabetes Association).
  • May 2015: Date of approval of Synjardy by the European Medicines Agency.
  • 4 years: Duration of the BI-Lilly Diabetes alliance pipeline producing FDA-approved medicines.

Sources:

  • Eli Lilly and Company, American Diabetes Association.