FDA expands indication for Synjardy to treatment-naive adults with type 2 diabetes

The FDA has approved an expanded indication for Synjardy to include treatment-naive adults with type 2 diabetes, Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company announced in a press release.

Synjardy, a combination of the SGLT-2 inhibitor Jardiance (empagliflozin) and metformin, is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both empagliflozin and metformin is appropriate.

“Type 2 diabetes is a complex condition, which often requires that people take more than one treatment to manage their blood sugar,” Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals, said in the release. “The expanded indication for Synjardy further validates the potential of 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 drug label was updated to include results from a phase 3 double-blind, randomized, active-controlled study that evaluated the efficacy and safety of empagliflozin in combination with metformin as initial therapy compared with the individual components. In the study, at 24 weeks, the combination of empagliflozin 10 mg or 25 mg with metformin 1,000 mg or 2,000 mg resulted in significant HbA1c reductions vs. either component alone.

The therapy is not designed for people with type 1 diabetes or diabetic ketoacidosis. The drug contains a Boxed Warning for the risk for lactic acidosis, which can occur due to metformin accumulation during treatment.

The FDA approved empagliflozin and metformin combination therapy in August 2015, based on the results of multiple clinical trials examining the coadministration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with type 2 diabetes.