The FDA's demanding requirements on cardio safety data has made diabetes one of the most challenging diseases in the drug development world. Today, Eli Lilly ($LLY) demonstrated that its late-stage diabetes drug dulaglutide cleared an important cardiovascular safety hurdle, impressing analysts with a savvy clinical game plan on an important experimental product in its pipeline.
Eli Lilly CEO John Lechleiter has already made it clear that dulaglutide is one of the company's top blockbuster hopefuls in its late-stage pipeline. Now investigators have data from a mid-stage study of 755 patients--two thirds of whom were diagnosed as hypertensive--demonstrating that dulaglutide is comparable with a placebo in its effect on systolic blood pressure.
In addition, Lilly reported, "the 1.5 mg dulaglutide dose significantly reduced mean 24-hour SBP (systolic blood pressure) compared to placebo." And at the end of 16 and 26 weeks the drug--a once-weekly GLP1 therapy that could end up competing with Bydureon--significantly reduced average blood glucose levels.
"We are very encouraged by these clinical trial results, in addition to the rest of the clinical trial data we've seen to date for dulaglutide," said Gwen Krivi, Ph.D., vice president of product development at Lilly Diabetes in a statement. "Dulaglutide is currently in Phase III clinical trials, where it will continue to be evaluated on its efficacy to lower blood glucose levels, overall safety, weight effects and effects on cardiovascular outcomes. We believe dulaglutide, if approved, can bring significant benefits to people with type 2 diabetes."