With a European approval for chronic kidney disease nod in hand, Boeringer Ingelheim and Eli Lilly's Jardiance is looking to catch up to AstraZeneca's Farxiga in this use and continue growing its reach.
The European Commission (EC) has granted an approval to Jardiance to treat adults with chronic kidney disease, Lilly and Boehringer said Tuesday. The nod was based on the EMPA-KIDNEY study, which demonstrated the drug's ability to reduce disease progression or death by 28% compared with placebo.
Also in the study, the drug cut the risk of hospitalization by 14% over placebo. Jardiance is the first SGLT2 inhibitor to pull off a reduction in all-cause hospitalizations in the CKD patient population, according to the partners.
In Europe, hospitalizations comprise up to 70% of total healthcare costs for CKD patients.
CKD affects some 47 million people across Europe, according to the companies. The drug was already approved to treat diabetes and heart failure.
This label expansion, and a potential forthcoming nod in the U.S., will likely help the companies as they work to grow Jardiance.
Last year, Jardiance brought in 5.8 billion euros ($6.1 billion), a 39% increase from 2021. In 2021, the drug grew sales 29% after moving into the heart failure arena.
Next up is an FDA decision on Jardiance’s use in chronic kidney disease. The agency accepted the partners' application in January and a decision is slated for “later this year,” Lilly’s vice president of product development Jeff Emmick, M.D., Ph.D., said at the time.
Meanwhile, AstraZeneca’s rival SGLT2 Farxiga beat Jardiance to the chase in CKD by winning an FDA nod in the disease back in 2021. The following year, the drug grew sales 46% to $4.4 billion.