The U.S. Food and Drug Administration has accelerated the review process for Jardiance (empagliflozin) as a treatment for chronic kidney disease (CKD), marking a significant development in the expanding therapeutic potential of SGLT2 inhibitors. The fast-track designation aims to evaluate the drug's ability to reduce the risk of kidney failure and cardiovascular death in CKD patients.
The decision follows compelling data from the EMPA-REG OUTCOME trial, where Jardiance demonstrated a 39% reduction in the risk of new-onset and worsening kidney disease among adults with diabetes and cardiovascular disease compared to placebo. This expansion could represent a crucial advancement in addressing a condition that affects approximately 700 million people worldwide.
Clinical Evidence and Ongoing Research
The fast-track designation is supported by both the EMPA-REG OUTCOME results and the ongoing EMPA-KIDNEY trial. The latter study specifically examines kidney disease progression and cardiovascular death in patients with established CKD, both with and without diabetes. Results from EMPA-KIDNEY are anticipated in 2022.
Dr. Waheed Jamal, Boehringer's head of cardiometabolic medicine, emphasizes the significance of addressing CKD, noting its prevalence as a leading cause of death globally.
Market Dynamics and Competition
Jardiance currently leads the SGLT2 inhibitor market, though competition in the CKD space is intensifying. Johnson & Johnson's Invokana (canagliflozin) became the first SGLT2 inhibitor approved for CKD in diabetic patients in October, based on the CREDENCE trial results. AstraZeneca's Farxiga (dapagliflozin) has also received FDA fast-track designation for CKD treatment in patients with and without diabetes.
Commercial Performance
The SGLT2 inhibitor market has shown significant growth, with Jardiance achieving a 43% increase in Eli Lilly's booked sales to $944 million last year. Boehringer Ingelheim reported over $2 billion in Jardiance sales in 2018. The drug's expanding indications, including its fast-track designation for reducing cardiovascular death and hospitalization risks in chronic heart failure patients, position it for continued growth in the cardiometabolic space.
The potential CKD indication could further strengthen Jardiance's market position, particularly as the drug has avoided the safety concerns that have affected some competitors. This expansion into CKD treatment aligns with the growing recognition of SGLT2 inhibitors' potential beyond their original use in type 2 diabetes management.
