Diabetes Med Receives Expanded Indication
The US Food and Drug Administration (FDA) approved an expanded indication for empagliflozin and metformin (Synjardy). The medication is now approved for use in treatment-naïve patients with type 2 diabetes.
The safety and efficacy was established on the results of a Phase III randomized, double-blind, active controlled study. The study showed that at 24 weeks, patients taking 10 mg or 25 mg of empagliflozin and 1000 mg or 2000 mg of metformin in combination experienced significant reductions in A1C when compared to patients taking either medication alone.
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“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,” said Paul Fonteyne, president and CEO of Boehringer Ingelheim Pharmaceuticals, said in a statement.
Taking the medication can result in serious side effects including lactic acidosis.
The medication was originally approved in the United States in 2015.
It is made by Boehringer Ingelheim and Eli Lilly and Company.
--Stephanie Vaccaro
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