European Commission approves empagliflozin

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, according to a press release.

Today, the Boehringer Ingelheim and Lilly Diabetes alliance announced the approval of Jardiance (empagliflozin), the newest sodium glucose co-transporter-2 (SGLT2) on the market.

“In Europe, the number of people with type 2 diabetes is growing and management of the condition increasingly requires a holistic approach for individuals and their needs,” Klaus Dugi, MD, PhD, chief medical officer, Boehringer Ingelheim, said in the release. “We aim to bring the very latest therapy options to people living with type 2 diabetes and are delighted empagliflozin will become available in Europe.”

The European Commission endorsed empagliflozin for approval in March, after the United States’ Food and Drug Administration 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, according to previous press releases.

Today’s European approval is based on more than 10 international trials looking at more than 13,000 adults with type 2 diabetes, according to the release. The phase 3 studies produced significantly reduced HbA1c, body weight and blood pressure when used as monotherapy and in combination with preexisting treatments. Hypoglycemia was the most common adverse event and seen most often in conjunction with sulfonylureas. As with other SGLT2 medications, genital infection and urinary tract infections were common side effects.

“The approval of empagliflozin marks the third diabetes product from the Boehringer Ingelheim and Lilly Diabetes alliance to be approved in Europe,” Enrique Conterno, president of Lilly Diabetes, said. “We are proud to continue with our commitment in supporting the varied treatment needs of people living with type 2 diabetes.”