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…
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…
50 of 2021’s best-selling pharmaceuticals
Drug sales in 2021 hit record heights, with a handful of pharmaceutical companies handsomely rewarded for creating COVID-19 vaccines and treatments. This roundup of best-selling pharmaceuticals in 2021 highlighted a banner year for the industry. Pfizer alone raked in $36.9 billion in sales from the Comirnaty vaccine it developed jointly with BioNTech. Demand for the…
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…
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…