Boehringer Ingelheim and Eli Lilly are celebrating this morning after getting the green light from regulators in Europe for their latest diabetes offering Jardiance.
The European Commission has granted marketing authorisation for Jardiance (empagliflozin), a member of the new sodium glucose co-transporter 2 (SGLT2) inhibitor class. The once-daily tablet can be used alone when metformin is not considered appropriate or alongside other glucose-lowering medicines including insulin.
The approval is based on a clinical trial programme that involved over 13,000 patients and results showed that empagliflozin 10 and 25 mg provided a significant lowering in blood sugar and clinically relevant reductions in body weight and blood pressure. There is much interest in SGLT2 inhibitors where compounds remove excess glucose through the urine by blocking glucose re-absorption by the kidney and the class is currently led by AstraZeneca's Forxiga /Farxiga (dapagliflozin) and Johnson & Johnson's Invokana (canagliflozin).
Klaus Dugi, Boehringer's chief medical officer, noted that 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". Jardiance is the third product from the Boehringer/Lilly diabetes alliance to be approved in Europe, following green lights for the DPP-4 inhibitor Trajenta (linagliptin) and Jentadueto (linagliptin/metformin).
Approval in Europe has been much smoother than across the Atlantic. In March, the US Food and Drug Administration issued a complete response letter, referencing "previously-observed deficiencies" at a Boehringer facility where empagliflozin will be manufactured. The agency stated that these need to be resolved before approval of the application and did not request any new clinical trials.