The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim’s Synjardy XR tablets for adults with type 2 diabetes. When used along with diet and exercise, Synjardy XR is indicated to improve blood sugar in adults with type 2 diabetes when both empagliflozin and metformin can be taken.
Besides German’s subsidiary in the US, this diabetes drug is marketed by Eli Lilly.
Synjardy XR is a combination of medicines empagliflozin and metformin which help improve blood glucose in adults with type 2 diabetes. Empagliflozin, a sodium-glucose co-transporter 2 inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Synjardy XR is the fourth FDA-approved treatment that contains empagliflozin. Metformin, a commonly prescribed initial treatment for type 2 diabetes, lowers glucose production by the liver and its absorption in the intestine.
“Adults with type 2 diabetes often take multiple medications, sometimes more than once a day, to manage their condition,” said Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals. “With SynjardyXR, the eighthFDA-approved treatment to emerge from our partnership with Lilly, adults with type 2 diabetes now have another convenient daily option to help them reach their glycemic goals, whether they are already being treated or are just at the beginning of their treatment.”
The FDA approval of Synjardy XR is 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. Synjardy XR is not for the treatment of type 1 diabetes or diabetic ketoacidosis.
Serious side effects
SynjardyXR can cause serious side effects, including lactic acidosis (a buildup of lactic acid in the blood). Metformin, one of the medicines in SYNJARDY XR, can cause lactic acidosis, a rare, but serious condition that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital. Synjardy XR can cause dehydration, low blood pressure and increased ketones in the blood (ketoacidosis).
Type 2 diabetes in the USA
Approximately 29 million Americans and an estimated 415 million people worldwide have diabetes.
In the U.S., approximately 12 percent of those aged 20 and older have diabetes. Type 2 diabetes is the most common type, accounting for an estimated 90 to 95 percent of all diagnosed adult diabetes cases in the U.S.