The European Commission has granted Marketing Authorisation for empagliflozin, a sodium glucose cotransporter 2 (SGLT2) inhibitor from Boehringer Ingelheim and Eli Lilly and Company. Empagliflozin has been approved for the treatment of Type 2 Diabetes (T2D) to improve glycaemic control in adults and will be marketed in Europe as Jardiance®.
The European Commission approved empagliflozin 10 and 25mg once daily tablets for use when diet and exercise alone do not provide adequate glycaemic control:
- alone when metformin is not considered appropriate due to intolerance
- alongside other glucose-lowering medicines including insulin when glucose control is inadequate.(1)
“In Europe, the number of people with Type 2 Diabetes is growing and management of the condition increasingly requires a holistic approach to individuals and their needs,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “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 Phase III clinical trial programme that supported empagliflozin’s Marketing Authorisation enrolled over 13,000 patients. Results from the programme showed empagliflozin 10 and 25mg provided a significant reduction in blood sugar from baseline values. Both empagliflozin groups also demonstrated clinically relevant reductions from baseline values in body weight and blood pressure.(1) When used as monotherapy, most adults did not experience side effects such as weight gain, low blood sugar and gastrointestinal issues.(2) Common side effects experienced with empagliflozin were genital infection, urinary tract infection and increased urination. Genital infection and urinary tract infection were more common in women than men.(3)
“The approval of empagliflozin marks the third diabetes product from the Boehringer Ingelheim and Lilly Diabetes alliance to be approved in Europe,” said Enrique Conterno, President of Lilly Diabetes. “We are proud to continue with our commitment in supporting the varied treatment needs of people living with Type 2 Diabetes.”
- Jardiance® (empagliflozin) tablets. EMA Summary of Product Characteristics. Approval 22 May 2014.
- Hach T, et al. Empagliflozin improves glycaemic parameters and cardiovascular risk factors in patients with Type 2 Diabetes mellitus (T2DM): Pooled data from four pivotal Phase III studies. Poster 943 on 23-27 September 2014 at the European Association for the Study of Diabetes (EASD) 2013, Barcelona, Spain.
- Kim G, et al. Urinary tract infections (UTIs) and genital infections: Pooled data from four empagliflozin (EMPA) pivotal Phase III trials Poster 74-LB on 21–25 June 2013 at the 73rd Scientific Sessions of the American Diabetes Association (ADA) 2013, Chicago, USA.