Signing Paper

Boehringer Ingelheim and Eli Lilly Announce Resubmission of NDA for Type 2 Diabetes Drug

June 18, 2014

Boehringer Ingelheim and Eli Lilly announced they have resubmitted an NDA for an investigational type 2 diabetes treatment, a sodium glucose co-transporter-2 (SGLT2) inhibitor, empagliflozin.

The Class 1 resubmission comes on the heels of a complete response letter issued by the FDA that referred to deficiencies previously seen at a BI facility where empagliflozin will be manufactured.

The FDA did not ask Boehringer Ingelheim to complete any new clinical trials to support the approval of the application, the Germany-based drugmaker said.

An investigational SGLT2 inhibitor, empagliflozin is being studied for the reduction of blood glucose levels in adult patients with diabetes. The SGLT2 inhibitor works by blocking glucose re-absorption in the kidney, removing excess glucose through the urine.

Empagliflozin was evaluated in one of the largest clinical studies in its class, BI said, consisting of 10 multinational clinical trials, involving more than 13,000 adults with type 2 diabetes.

Over a two year period, empagliflozin in combination with certain other diabetes therapies showed reductions in blood glucose, body weight and blood pressure compared with glimepiride, the drugmaker said. — Kellen Owings

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