Lilly, BI apply for diabetes drug approval

Drug makers, partners since January 2011, submit application to FDA for empagliflozin

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

"We are excited to have submitted an application for a potential new treatment option that may help patients better manage their Type 2 diabetes mellitus," BI VP metabolic-clinical development and medical affairs Christophe Arbet-Engels said. "Type 2 diabetes mellitus is a critical health issue facing the world today, and through Boehringer Ingelheim and Lilly Diabetes Alliance, we are committed to developing new treatments to address patients with this disease."

The submission is part of a partnership between the two companies announced in January 2011.

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