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| Eli Lilly corporate headquarters in Indianapolis |
After a manufacturing issue spiked its pitch for FDA approval, a new diabetes drug from Eli Lilly ($LLY) and Boehringer Ingelheim has secured European clearance, lining up to compete in a crowded market.
Empagliflozin, to be marketed as Jardiance, is a Type 2 diabetes treatment that blocks SGLT2 proteins, stopping glucose absorption in the kidney and leading the body to dispel excess sugars through the urine. In Phase III studies, the drug significantly reduced hemoglobin A1c--a common biomarker for diabetes--as well as body weight and blood pressure, the companies said. Like other SGLT2 blockers, the oral treatment carries the risk of genital and urinary tract infections.
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| BI corporate headquarters in Germany |
Meanwhile, Lilly, Boehringer and their diabetes alliance are still smarting over the FDA's rejection of empagliflozin earlier this month. The agency found no problems with the drug's safety or efficacy profile, the duo said, but instead cited manufacturing issues at the Boehringer plant where it would be produced, holding off approval until the German drugmaker took care of some "previously observed deficiencies." The companies haven't issued an update on the drug's future with the FDA, and Lilly said in an email Friday only that they plan to submit a response to the agency "as soon as possible."
Empagliflozin's European success marks the third approval for Lilly and Boehringer, who paired up in diabetes in 2011, but the two are hardly first-movers in the SGLT2 field. Johnson & Johnson ($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. Analysts figure the market for SGLT2 inhibitors could peak at close to $2 billion around the world, but just how much of that haul will fall to Boehringer and Lilly remains to be seen.
The European Medicines Agency has made no mention of the manufacturing problems that have delayed empagliflozin's U.S. application, and Boehringer and Lilly are moving right along with their plans for a near-term EU launch.
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| BI CMO Klaus Dugi |
"In Europe, the number of people with Type 2 diabetes is growing, and management of the condition increasingly requires a holistic approach for individuals and their needs," Boehringer CMO Klaus Dugi said in a statement. "We aim to bring the very latest therapy options to people living with Type 2 diabetes and are delighted empagliflozin will become available in Europe."
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