The US Food and Drug Administration has given its consent for the inclusion of clinical trial data showing a reduction in the risk of death with three type II diabetes medicines from the empagliflozin family.
The regulator has approved supplemental New Drug Applications seeking permission to include data from the EMPA-REG OUTCOME trial, which showed that empagliflozin reduced the risk for cardiovascular death compared with placebo when added to standard of care type II diabetes and cardiovascular medicines in adults with both conditions.
Trial results showed that empagliflozin significantly reduced the relative risk of the combined primary endpoint of cardiovascular death, non-fatal heart attack or non-fatal stroke by 14 percent versus placebo.
The data have been added to the 'Clinical Studies' sections of the prescribing information for Synjardy (empagliflozin/metformin hydrochloride), Synjardy XR (empagliflozin/metformin hydrochloride extended-release) and Glyxambi (empagliflozin/linagliptin) tablets, all of which are marketed by Boehringer Ingelheim and Eli Lilly.
"The addition of these data to the Synjardy, Synjardy XR and Glyxambi labels will help physicians better understand the available clinical trial evidence to help their patients who have type II diabetes and cardiovascular disease," said Thomas Seck, vice president, Clinical Development and Medical Affairs, Primary Care, at Boehringer.