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Lilly and Boehringer’s Jardiance, chasing AZ, nabs speedy FDA review in kidney disease

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. 

In June, Boehringer and Lilly unveiled data from their Empa-Reg outcomes study showing Jardiance lowered the risk of new or worsening kidney disease versus placebo independent of whether patients’ blood pressure, glucose levels and cholesterol levels were being controlled by medication.

The pair followed that data with a subanalysis in September showing Jardiance’s positive effects on cardiovascular and kidney outcomes were consistent whether or not patients had advanced kidney disease.

A nod in the kidney disease arena would help Jardiance keep pace with SGLT2 rivals Invokana from Johnson & Johnson Invokana and Farxiga from AstraZeneca. Invokana fired the first broadside in September with an FDA nod to treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes patients and diabetic kidney disease. 

A month earlier, the British drugmaker nabbed its own FDA fast track designation to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with chronic kidney disease. 

A nod in kidney disease would also help Jardiance keep pace with Farxiga, which boasts its own speedy FDA review for an indication to reduce the risk of CV death or stroke in heart failure patients with or without diabetes.

In December, Jardiance flopped its own trial in that holy grail population after failing to improve exercise ability over placebo in those patients, according to top-line data from two phase 3 studies, Emperial-Reduced and Emperial-Preserved.  

That setback was only the most recent for Jardiance after an FDA advisory committee voted in November against recommending a 2.5-milligram dose of the drug on top of insulin in Type 1 diabetes patients.