AstraZeneca's SGLT2 Inhibitor, Forxiga, Receives Marketing Authorization from EMA for Diabetes Treatment
First SGLT2 Inhibitor to Receive EMA Marketing Authorization
The European Medicines Agency (EMA) approved AstraZeneca's Forxiga (dapagliflozin), a type 2 diabetes treatment, on November 11, 2012. This signifies the commercialization of a novel treatment that blocks sodium-glucose cotransporter 2 (SGLT2) in the kidneys, thereby excreting glucose in the urine. It is considered the first case to revolutionize diabetes treatment from an insulin-dependent approach to a non-insulin-dependent approach. This approval was based on robust blood glucose-lowering and safety data demonstrated in 11 Phase 3 clinical trials.
Demonstrated Differentiated Therapeutic Efficacy Based on Phase 3 Data
Forxiga demonstrated superior HbA1c reduction compared to existing standard of care (SoC) in Phase 3 clinical trials involving a total of over 5,600 patients. In particular, it showed consistent glycemic control not only as monotherapy but also in combination therapy with metformin or insulin. Furthermore, it showed additional benefits such as weight loss and reduction in systolic blood pressure (SBP), which can contribute to the improvement of obesity and hypertension, major complications of diabetes. These multifaceted efficacies serve as important clinical evidence to increase the prescription priority for diabetic patients with high cardiovascular risk.
Global Market Positioning and Securing Competitive Advantage
Forxiga is in fierce competition with Jardiance (empagliflozin) from Eli Lilly and Boehringer Ingelheim, and other drugs in the same class, for market share. However, thanks to AstraZeneca's strong cardiovascular and metabolic disease portfolio and global sales network, it has been able to rapidly expand its market dominance. In particular, it achieved sales of $7.71 billion in 2024 and $8.41 billion in 2025, solidifying its position as a global blockbuster drug. It is analyzed that the strategy of overcoming strict price negotiations in each European country and inducing reimbursement prescriptions was effective in achieving early market penetration.
Expansion of Indications to Cardiovascular and Renal Protection and Future Prospects
Forxiga started as a type 2 diabetes treatment, but has significantly expanded its indications through large-scale clinical studies, DAPA-HF and DAPA-CKD. It has demonstrated unparalleled long-term protective efficacy in reducing mortality and hospitalization rates in patients with chronic heart failure and chronic kidney disease, regardless of diabetes status. As a result, it has evolved from a simple blood glucose-lowering agent to an essential treatment for heart and kidney diseases, securing long-term growth momentum. In the future, it is expected to lead the expansion of the global SGLT2 inhibitor market in line with the increasing population of chronic diseases due to aging.
This EMA approval for Forxiga establishes SGLT2 inhibitors as a new standard of care (SoC) in the diabetes treatment market, which has traditionally been insulin-centric, and elevates AstraZeneca's metabolic disease business unit as a core growth driver. In the short term, it provides strong clinical evidence to maximize the prescription gains in the European market against competing drugs in the same class, such as Jardiance from Eli Lilly. In the medium to long term, it has successfully expanded its indications beyond diabetes to chronic heart failure (Phase 3 completed and approved) and chronic kidney disease, which has become a catalyst for expanding the global SGLT2 market to over $20 billion. As a result, this approval has significantly improved AstraZeneca's medium- to long-term cash flow and R&D investment capabilities for next-generation pipelines by securing blockbuster sales of over $8 billion annually before patent expiration.
Source: EMA (ema)