Jardiance, which was approved in Europe in May of this year, was late in coming because of certain issues raised by the FDA at Boerhringer's manufacturing plant.
The agency approved empagliflozin, to be marketed as Jardiance, as an oral treatment for the nation's more than 26 million Type 2 diabetics. The drug works by blocking SGLT2 proteins, stopping glucose absorption in the kidney and leading the body to dispel excess sugars through the urine. In Phase III studies, Jardiance significantly reduced hemoglobin A1c--a common biomarker for diabetes--as well as body weight and blood pressure, the companies said.
The FDA's nod comes about 5 months later than Lilly and Boehringer had hoped, after some "previously observed deficiencies" at a plant belonging to the latter company led the agency to prolong its decision. The pair picked up European approval for Jardiance in May.
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