Lilly gets FDA review for empagliflozin in chronic kidney disease

The FDA has accepted a supplemental New Drug Application (sNDA) for Jardiance (empagliflozin) tablets as a potential therapy to reduce the risk of kidney disease progression and cardiovascular death in adults with chronic kidney disease (CKD).

Some 37 million people in the U.S. have CKD.

Lilly (NYSE:LLY) is developing the drug with Boehringer Ingelheim.

The supplemental New Drug Application includes data from the landmark EMPA-KIDNEY Phase 3 study, which found that empagliflozin led to a significant reduction in the risk of kidney disease progression or cardiovascular death in adults with CKD. In the study, the drug on top of  standard of care reduced the risk of kidney disease progression or cardiovascular death in adults by 28% compared with placebo.

EMPA-KIDNEY is an abbreviation of Empagliflozin in the Management of Patients with Advanced Chronic Kidney Disease.

The randomized, double-blind, placebo-controlled study (NCT03594110) enroll…

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AstraZeneca’s Farxiga met primary endpoint in Phase 3 heart failure trial 

AstraZeneca’s (LON:AZN) SGLT2 inhibitor Farxiga (dapagliflozin) led to a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure in the DELIVER Phase 3 study. 

First FDA approved in 2014 as a type 2 diabetes treatment, Farxiga has scored approvals related to heart failure and chronic kidney disease. 

AstraZeneca now says that data from the DELIVER and DAPA-HF Phase 3 studies show its efficacy in heart failure regardless of ejection fraction. 

In the two studies, the safety profile of Farxiga was consistent with prior data.

Farxiga’s biggest competitor is Jardiance (empagliflozin) from Boehringer Ingelheim and Eli Lilly, first approved in 2014 for type 2 diabetes. Jardiance now has two FDA indications related to heart failure.

Another competitor is the heart failure drug Entresto (sacubitril/valsartan) from Novartis, which had $2.8 billion in sales in …

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Lilly stops Phase 3 Jardiance trial early thanks to clear positive efficacy data

The independent data monitoring committee overseeing the Phase 3 EMPA-KIDNEY trial investigating Lilly’s (NYSE:LLY) Jardiance (empagliflozin) concluded the therapy showed positive efficacy in a formal interim assessment.

Boehringer Ingelheim co-developed empagliflozin with Lilly.

The EMPA-KIDNEY trial focused on treating adults with chronic kidney disease (CKD).

The committee recommended that the Phase 3 study be stopped early, given clearly positive data.

Earlier, the Medical Research Council (MRC) Population Health Research Unit at the University of Oxford, Boehringer Ingelheim and Eli Lilly and Company (NYSE: LLY), concluded Jardiance met the prespecified positive efficacy criteria.

Jardiance was first FDA approved as a treatment for type 2 diabetes in 2014. An indication followed for reducing the risk of cardiovascular death in adults with type 2 diabetes in 2016.

Approvals followed in 2021 and 2022 for heart failure with r…

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FDA approves Lilly’s Jardiance for heart failure 

Eli Lilly and Company (NYSE:LLY) has announced that the FDA has approved Jardiance (empagliflozin) 10 mg to lower the risk of cardiovascular death and hospitalization in adults with heart failure.

Lilly developed the drug, an SGLT2 inhibitor, in collaboration with Boehringer Ingelheim.

Jardiance is contraindicated in adults with type 1 diabetes, given its potential to elevate the risk of ketoacidosis in such patients.

It is also contraindicated in patients who are hypersensitive to empagliflozin or the excipients in Jardiance.

FDA first approved Jardiance as a treatment for type 2 diabetes in 2014.

In 2016, it won an indication for reducing the risk of cardiovascular death in adults with type 2 diabetes.

Lilly also notes that the drug is not recommended for improving glycemic control in adults with type 2 diabetes with an estimated glomerular filtration rate (eGFR) under 30 mL/min/1.73 m2.

The company notes that the treatment …

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