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Boehringer Ingelheim announced Empagliflozin Phase III EMPA_KIDNEY trial will stop early due to clear positive efficacy in people with chronic kidney disease.
The Independent Data Monitoring Committee has recommended that the EMPA-KIDNEY trial evaluating the effect of empagliflozin in adults with chronic kidney disease (CKD) should be stopped early. The Medical Research Council Population Health Research Unit at the University of Oxford, Boehringer Ingelheim, and Eli Lilly announced that this was due to a formal interim assessment that deemed the treatment to be effective based on prespecified criteria.
EMPA-KIDNEY evaluated the efficacy and safety of empagliflozin in certain adults with CKD, including those with mildly to severely reduced eGFR (a measure of kidney function), those with normal and increased levels of albumin (a type of protein present in the urine), those with and without diabetes, and those with CKD attributable to a wide range of underlying diseases.
“As part of the larger community dedicated to helping the millions of people living with chronic kidney disease, the early stop of EMPA-KIDNEY brings us one step closer to achieving this goal much sooner,” said Waheed Jamal, M.D., corporate vice president and head of CardioMetabolic Medicine, Boehringer Ingelheim, in a press release. “EMPA-KIDNEY adds to the success of the EMPOWER trial program which has already demonstrated cardio-renal and metabolic benefits of empagliflozin for millions of people across the globe.”
“EMPA-KIDNEY included a range of adults with kidney disease who have been excluded from, or under-represented in, previous trials focusing on the use of SGLT2 inhibitors to slow kidney disease progression,” said Jeff Emmick, M.D., PhD, vice president, product development, Lilly, in a press release. “The early stop of the trial is a tremendous step toward our goal of improving the lives of adults living with kidney disease.”
Source: Boehringer Ingelheim