Empagliflozin (an SGLT2 inhibitor) Approved by European Commission
The European Commission has approved empagliflozin 10 mg and 25 mg once-daily tablets for use in adults when glycemic control is not achieved from diet and exercise. The European Commission endorsed empagliflozin for approval in March after the U.S. FDA delayed the approval and requested more data. A new drug application has been accepted by the FDA for a combination of empagliflozin and linagliptin, though, and will be reviewed. This approval is based on more than 10 international trials looking at more than 13,000 adults with type 2 diabetes. The phase 3 studies produced significantly reduced HbA1c, body weight and blood pressure when used as monotherapy and in combination with preexisting treatments. Lilly News Release, Mau 2014
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