FDA Expands Indication for Diabetes Drug

The FDA has expanded indication for the type 2 diabetes (T2D) drug empagliflozin/metformin hydrochloride (Synjardy) to include treatment naïve adults.

Synjardy is a combination of the 2 diabetes drugs empagliflozin (Jardiance) and metformin and helps control blood glucose in adults with T2D.

“Type 2 diabetes is a complex condition, which often requires that people take more than 1 treatment to manage their blood sugar,” said Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals, Inc. “The expanded indication for Synjardy further validates the potential for this combination therapy to help adults with type 2 diabetes who are not at goal, including those already being treated and, now, those at the beginning of their treatment journey.”

The expanded label was based on the results from a double-blind, randomized, active-controlled, phase 3 study that evaluated the safety and efficacy of empagliflozin plus metformin as initial therapy compared with the components used individually.

Patients were administered the combination of empagliflozin 10-mg or 25-mg with metformin 1000-mg or 2000-mg. At 24 weeks, there were significant reductions in A1C compared with the corresponding doses of each component alone.

Serious side effects for Synjardy include Lactic Acidosis and metformin is one of the medicines in Synjardy that can cause this rare, but serious condition.