6 July 2018 - - Ingelheim, Germany-based pharmaceutical company Boehringer Ingelheim and Indianapolis, Indiana-based global pharmaceuticals specialist Eli Lilly and Company (NYSE: LLY) have received a positive opinion from the European Medicines Agency Committee for Medicinal Products for Human Use to update the labels of Jardiance (empagliflozin), Synjardy (empagliflozin and metformin), and Glyxambi (empagliflozin and linagliptin) to include additional important data from the EMPA-REG OUTCOME trial on heart failure and kidney endpoints, the companies said.
The labels now include a relative risk reduction in hospitalisation for heart failure by 35% and a relative risk reduction for new-onset or worsening of kidney disease by 39% with empagliflozin, a highly selective sodium glucose cotransporter 2 (SGLT2) inhibitor, compared with placebo, in people with type 2 diabetes and established cardiovascular disease.
EMPA-REG OUTCOME is a long-term, multinational, randomised, double-blind, placebo-controlled clinical trial of more than 7,000 people from 42 countries with type 2 diabetes and established cardiovascular (CV) disease assessing the effect of empagliflozin (10 mg or 25 mg once daily) added to standard of care compared with placebo added to standard of care.
Boehringer Ingelheim operates globally with approximately 50,000 employees in three business areas including human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing.
Lilly employees work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to communities through philanthropy and volunteerism.