The U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company’s Glyxambi for treatment of adults with type 2 diabetes.
Glyxambi is the first and only diabetes treatment in the U.S. to combine the dual mechanisms of ....
Tag: Jardiance
The FDA has issued a complete response letter to Boehringer Ingelheim and Eli Lilly for the New Drug Application (NDA) of the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin.
The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured.
Eli Lilly and Boehringer Ingelheim presented new data from a phase 2b open-label extension study, showing empagliflozin (BI 10773), alone or as an add-on to metformin, reduced hemoglobin A1c (HbA1c or A1c) levels, fasting plasma glucose (FPG) levels and body weight when given to adults with type 2 diabetes for up to 90 weeks...