Germany-based Boehringer Ingelheim and United States-based Eli Lilly and Company (NYSE: LLY) announced on Friday that the US Food and Drug Administration has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets.

Jardiance is being assessed as a potential treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).

The sNDA is based on outcome from the landmark EMPA-KIDNEY phase III trial. In the trial, it is claimed that Jardiance significantly reduced the risk of kidney disease progression or cardiovascular death in adults with CKD by 28% (ARR: 3.8%) compared with placebo, both on top of standard of care.

Jeff Emmick, MD., PhD., vice president, Product Development, Lilly, said, 'This marks another exciting milestone for Jardiance, potentially extending its ability to positively impact the approximately one billion people diagnosed with a cardio, renal or metabolic condition. We look forward to working with the FDA during the review process and eagerly await a decision later this year on the indication for CKD, which doubles a person's risk for hospitalisation.'