Boehringer Ingelheim and Eli Lilly announced Monday that the main goal of a significant change in HbA1c from baseline compared to placebo was met in four Phase III studies of the experimental drug empagliflozin in patients with type 2 diabetes. The companies said they expect to file marketing applications for the SGLT-2 inhibitor in the US, Europe and Japan in 2013.
In the four studies, which enrolled a total of 3730 patients, two doses of empagliflozin were evaluated as a monotherapy or in combination with other drugs. Boehringer Ingelheim and Eli Lilly said that although the incidence of adverse events was similar between the empagliflozin and placebo groups, genital infections were more common in patients taking empagliflozin at both dosages. The drugmakers added that the safety findings were consistent with those of Phase II studies. Detailed results from the trials will be presented at medical meetings in 2013 and 2014.
In related news, Eli Lilly noted that Boehringer Ingelheim decided to terminate the drugmakers' collaboration related to another diabetes therapy called LY2605541, citing "independent strategic portfolio considerations." Eli Lilly announced that it will continue clinical trials of the insulin analogue, and could submit the medicine for regulatory approval as early as 2014 if late-stage studies are successful.
Both empagliflozin and LY2605541 formed part of Boehringer Ingelheim and Eli Lilly's 2011 deal to jointly develop and market four diabetes compounds. "We are committed to the continued success in our partnership to develop and commercialise the other molecules within the alliance, including Tradjenta...empagliflozin and LY2963016, a new insulin glargine product," remarked Ulrich Drees, corporate senior vice president of international project management at Boehringer Ingelheim.
To read more Top Story articles, click here.