BIPI, Lilly announce resubmission of empagliflozin NDA to FDA for treatment of type 2 diabetes

Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company (NYSE: LLY) today announced the resubmission of a New Drug Application (NDA) for the investigational sodium glucose co-transporter-2 (SGLT2) inhibitor empagliflozin for the treatment of adults with type 2 diabetes (T2D) to the U.S. Food and Drug Administration (FDA). The Class 1 resubmission follows a complete response letter issued by the FDA that referenced previously observed deficiencies at a Boehringer Ingelheim 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.

"We are very pleased to move forward with resubmission of the empagliflozin NDA following a FDA inspection of the Boehringer Ingelheim facility referenced in the complete response letter," said Paul Fonteyne, president and chief executive officer, Boehringer Ingelheim Pharmaceuticals, Inc. "We believe in the potential of empagliflozin and hope to provide another treatment option in the near future to adults with type 2 diabetes."

Empagliflozin is an investigational SGLT2 inhibitor being studied for the reduction of blood glucose levels in adults with diabetes. The SGLT2 inhibitor class removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Empagliflozin was studied in one of the largest clinical trial programs in its class, comprised of more than 10 multinational clinical trials and more than 13,000 adults with type 2 diabetes.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
AI-based video system may offer quick, no-contact screenings for high blood pressure and diabetes