logo
  

Boehringer, Lilly Report Positive Top-line Phase III Empagliflozin Results

Boehringer Ingelheim and Eli Lilly and Co. (LLY) announced top-line results for four completed Phase III trials for empagliflozin, an investigational sodium glucose co-transporter-2 or SGLT-2 inhibitor being studied for type 2 diabetes or T2D treatment.

The company said that incidence of adverse events was similar for placebo, empagliflozin 10mg and 25mg, while genital infections occurred more often with empagliflozin compared with placebo. This safety information is consistent with findings reported in the Phase II trial results for empagliflozin.

Empagliflozin is being investigated in adults with T2D in a Phase III study program, which would enroll more than 14,500 patients. Totally, this program consists of eight multinational trials, including a large cardiovascular outcome trial. The pivotal studies for empagliflozin completed in 2012, and Boehringer Ingelheim and Lilly anticipate filing for regulatory review in the U.S., Europe and Japan in 2013. Boehringer Ingelheim and Lilly intend to present detailed data disclosures for many of these studies at scientific medical meetings and publications in 2013 and 2014.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
MTD Products Inc. is recalling 1,774 units of walk-behind self-propelled lawn mowers for potential risk of fire hazard, a statement by the U.S. Consumer Product Safety Commission (CPSC) showed. The company said the lawn mower can leak fuel when it is stored in the upright (vertical) storage position to pose a fire hazard. Nike Inc. announced its plans to exit the Russian market completely following Russia's ongoing war against Ukraine, reports said. The sportswear major, with more than 100 stores in the country, had suspended operations there in March. Earlier in March, while suspending operations temporarily, the company had said its customers that it couldn't guarantee product shipments. The U.S. Food and Drug Administration unveiled its action plan to advance drug development for rare neurodegenerative diseases, including Amyotrophic Lateral Sclerosis or ALS, in five years. The FDA plans specific actions such as regulatory science initiatives, enhancements to existing programs and new policy initiatives for the purpose. It will use public-private partnerships...
Follow RTT