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.
Now it’s on Lilly and Boehringer to shoulder their way into a densely packed market for SGLT2 inhibitors. Johnson & Johnson ($JNJ) is already on the U.S. and European markets with its Invokana (canagliflozin), and AstraZeneca ($AZN) finally picked up FDA approval for its long-delayed Farxiga (dapagliflozin) in January.
Safety worries have thus far limited uptake for the SGLT2 class, as the treatments have been linked to increased rates of genital and urinary tract infections, plus kidney damage and cardiovascular issues. As it did with Invokana and Farxiga before it, the FDA is requiring Jardiance to undergo a cardiovascular outcomes trial and a suite of pediatric studies to affirm its tolerability.
Jardiance’s approval is especially important for Lilly, which, facing a slew of patent expirations, is counting on near-term launches to return it to growth. Diabetes is of particular importance to the slow-footed drugmaker, which is nearing the market with dulaglutide, a potential blockbuster GLP-1 treatment, and a biosimilar of Sanofi’s ($SNY) top-selling insulin Lantus.
– read the statement