By: Hannah Ishmael
On Friday, the US Food & Drug Administration (FDA) approved Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Co.’s (LLY) drug Jardiance (empagliflozin) as an add-on to diet and exercise to improve glycemic control (blood sugar levels) in adults with type 2 diabetes (T2D). The approval comes after the FDA had earlier rejected empagliflozin because of manufacturing deficiencies at Boehringer’s facility, where the drug is manufactured.The drug got approval once the company reported that the issue had been resolved.
On Friday, the US Food & Drug Administration (FDA) approved Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Co.’s (LLY) drug Jardiance (empagliflozin) as an add-on to diet and exercise to improve glycemic control (blood sugar levels) in adults with type 2 diabetes (T2D). The approval comes after the FDA had earlier rejected empagliflozin because of manufacturing deficiencies at Boehringer’s facility, where the drug is manufactured.The drug got approval once the company reported that the issue had been resolved.
Jardiance, available in two dosage strength types i.e. 10 mg or 25 mg, is a once-daily oral medication. It works by blocking the reabsorption of glucose in kidneys and by increasing glucose excretion to lower blood glucose levels in adults with T2D. The drug is not for people with type 1 diabetes or diabetic ketoacidosis (increased ketones in the blood or urine).
FDA approval for Jardiance is based on data from more than 10 multinational clinical trials and 13,000 adults with T2D, which revealed that the drug reduced hemoglobin A1C and blood sugar levels significantly after 24 weeks, in isolation or in combination with other treatments like metformin, sulfonylureas, insulin and pioglitazone. Modest weight loss was also observed in the trials; the drug, however, is not approved for weight loss. Common adverse reactions witnessed with Jardiance include urinary tract infections and vaginal yeast infections.
According to president of Lilly Diabetes Enrique Conterno: “Today'sFDAapproval of Jardiance provides an exciting new option in the treatment of adults with type 2 diabetes and demonstrates our commitment to these patients, as it marks the third diabetes medicine to emerge from our alliance pipeline.”
About 382 million people worldwide and 29 million Americans have diabetes. Type 2 diabetes, which is the most common, accounts for 85% to 95% of all cases.
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