Fast on the heels of winning a European approval to treat chronic kidney disease (CKD), Eli Lilly and Boehringer Ingelheim's versatile SGLT2 inhibitor Jardiance is expanding its reach in the U.S., too.
Friday, the companies said the FDA has signed off on Jardiance to treat adult patients with CKD.
Specifically, the drug is approved to reduce the risk of sustained decline in estimated glomerular filtration rate, end-stage kidney disease, cardiovascular death and hospitalization in adult patients who are at risk of progression.
The approval adds to the choice of treatment options for about 35 million adults in the U.S. suffering from CKD, the partners said in a release. It comes just months after the European Commission signed off on the drug's use in CKD.
Like in Europe, the FDA's approval is based on the results from the phase 3 EMPA-KIDNEY trial, which enrolled more than 6,600 patients. In the study, Jardiance demonstrated a 28% relative risk reduction versus placebo on the composite primary endpoint of kidney disease progression or cardiovascular death. Both groups in the trial also received standard of care.
Now, Jardiance will have a chance to face off against its in-class rival in CKD. Back in April 2021, AstraZeneca's SGLT2 inhibitor Farxiga won an FDA approval for the same use.
At the time, AZ touted the approval as the "most significant advancement" in treating CKD in two decades.
On the sales front, both drugs have been posting significant gains lately. Boehringer reported 3.5 billion euros ($3.83 billion) in sales from Jardiance in the first half of the year, while Eli Lilly said the drug pulled down $1.25 billion. Boehringer didn't reveal its rate of growth for Jardiance, but Lilly said its revenues from the drug had increased by 42% versus 2022's first half.
AZ's Farxiga reeled in $2.8 billion during the first half of this year, a 39% increase at constant exchange rates.
Aside from CKD, Jardiance boasts broad U.S. approvals in heart failure and diabetes.