FDA accepts supplemental new drug application for Jardiance for CKD
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The FDA accepted a supplemental new drug application for Jardiance, empagliflozin tablets, which may reduce kidney disease progression and cardiovascular death in adults with chronic kidney disease, according to the press release.
Boehringer Ingelheim and Eli Lilly and Company announced the news, which follows the 2020 fast track designation the drug gained for a clinical investigation.
The treatment was tested in the EMPA-KIDNEY phase 3 trial, where it reduced the risk of kidney disease progression or cardiovascular death in 6,609 adults with CKD by 28% compared with placebo. Either placebo or the treatment drug were given to patients in addition to standard of care. Researchers identified additional benefits to the empagliflozin tablets such as a reduction in hospitalization for heart failure or cardiovascular death or all-cause death, although these were not statistically significant.
In 2014, the treatment was approved as a daily tablet to lower blood sugar in adults with type 2 diabetes and to reduce the risk of cardiovascular death in adults with type 2 diabetes and CVD. In the EMPA-KIDNEY phase 3 trial, researchers tested the treatment in patients, including those without diabetes.
“This marks another exciting milestone for Jardiance, potentially extending its ability to positively impact the approximately 1 billion people diagnosed with a cardio, renal or metabolic condition,” Jeff Emmick, MD, PhD, vice president of product development at Eli Lilly, said in the release. “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 hospitalization.”
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