Lilly and Boehringer's Jardiance, chasing AZ, nabs speedy FDA review in kidney disease
Jardiance is the third SGLT2 med to score an approval or speedy review in kidney disease. (Eli Lilly)
In its quest to keep pace with rising SGLT2 rival Farxiga from AstraZeneca, Eli Lilly and Boehringer Ingelheim's Jardiance has had its fair share of stumbles in recent months. But in kidney disease, where the class is racing to snatch share, it just nabbed a fast-track boost from the FDA.
The agency Thursday teed up a speedy review to reduce kidney disease progression and cardiovascular death in patients with chronic kidney disease (CKD). CKD is the ninth-leading cause of death in the U.S. and affects around 30 million Americans each year, Lilly said.
The FDA will base its review on results from the ongoing Empa-Kidney study, which is examining Jardiance's effect on the progression of kidney disease and the occurrence of CV death in adults with established chronic kidney disease both with and without diabetes.