(Reuters) - A large study demonstrated the heart safety of Sanofi’s injectable type 2 diabetes drug lixisenatide and appears to rule out other potential health hazards as well, according to data presented at a medical meeting on Monday,
The results pave the way for the French drugmaker to file for U.S. approval of the medicine, which it said it plans to do in the third quarter of this year.
Lixisenatide is sold in Europe under the brand name Lyxumia. Sanofi withdrew its original U.S. application in 2013, deciding to wait for final results of the study called Elixa to prove it does not increase serious heart problems in diabetes patients.
Sanofi, under new Chief Executive Olivier Brandicourt, has been working to expand its diabetes portfolio beyond its top-selling Lantus insulin product. Chris Viehbacher lost the CEO job last year in part due to flagging U.S. Lantus sales.
In the study of 6,000 high-risk heart patients, most of whom had had a previous heart attack, adding lixisenatide to other standard diabetes treatments did not increase major adverse heart events any more than adding a placebo.
The study tested the rate of cardiovascular death, non-fatal heart attacks, non-fatal strokes and hospitalization for unstable angina. After just over two years, 13.4 percent of lixisenatide patients had experienced one of the major adverse events versus a nearly identical 13.2 percent in the placebo group.
Researchers also looked for other safety concerns that have been raised in the past with other diabetes medicines. They found no increase in acute pancreatitis, pancreatic cancer or hospitalizations for heart failure.
“That was the first thing we looked for and it seems absolutely clean,” Rachele Berria, head of Sanofi’s U.S. diabetes medical unit, said of the lack of a heart failure issue. “And the risk of hypoglycemia is just not there,” she added, referring to potentially dangerously low blood sugar.
The results were presented at the American Diabetes Association meeting in Boston.
Several companies have conducted large cardiovascular safety studies of their diabetes medicines after some older drugs raised heart risk concerns, many of which have since been disproved.
Lixisenatide, which is injected once daily to control blood sugar levels, belongs to a class of diabetes drugs called GLP-1 receptor agonists that mimic a naturally occurring hormone that stimulates insulin secretion. Elixa was the first major heart safety study for a medicine from this class, Sanofi said.
Reporting by Bill Berkrot in New York; Editing by Jeffrey Benkoe