FDA Approves Expanded Indication for Synjardy

The FDA has approved an expanded indication for type 2 diabetes treatment Synjardy (empagliflozin and metformin hydrochloride) to include treatment-naïve adults. Synjardy is designed to improve glycemic control in adults with type 2 diabetes.

The FDA based its decision on a phase 3, double blind, randomized, active-controlled study that looked at the efficacy and safety of empagliflozin and metformin as an initial therapy. After 24 weeks, the combination therapy showed significant reductions of A1C in patients, compared to those who were taking the corresponding dose of either ingredient alone.

"Type 2 diabetes is a complex condition, which often requires that people take more than one treatment to manage their blood sugar," said Paul Fonteyne, president and CEO of Boehringer Ingelheim, in a press 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."

More than 29 million adults in the US have diagnosed diabetes, and type 2 diabetes accounts for 95% of those cases. Meanwhile, 86 million US adults have prediabetes, where blood sugar levels are higher than average but not yet high enough to be classified as Type 2 Diabetes.

Lactic acidosis is a serious side effect of Synjardy. It is defined as the build-up of lactic acid in the blood, and it can potentially lead to death. However, the most common side effects are nausea, vomit, and tiredness.