Eli Lilly and Company and Boehringer Ingelheim recently announced that the US Food and Drug Administration (FDA) has accepted the filing of the New Drug Application (NDA) for LY2963016, an investigational basal (long-acting) insulin. LY2963016 is a new insulin glargine product developed for the treatment of patients with type 1 and type 2 diabetes.

The NDA was filed through the 505(b)(2) regulatory pathway, which allows the FDA to reference their previous findings of safety and efficacy data for an already-approved insulin glargine product, in addition to the studies of LY2963016.

Lilly and Boehringer Ingelheim designed the comprehensive development program for LY2963016 in order to meet the regulatory standards of clinical and nonclinical safety, efficacy and quality. In addition to comparative pharmacokinetic and pharmacodynamic studies, the NDA submission includes results from phase III studies that were conducted in patients with type 1 and type 2 diabetes, using a currently marketed insulin glargine product as the active comparator.

"The US regulatory submission for our new insulin glargine product demonstrates our progress in bringing another option to the millions of Americans with diabetes who require long-acting insulin as an integral part of their treatment plan," said Gwen Krivi, Ph.D., vice president, Lilly Diabetes product development. "This submission of the NDA for this product helps us realize the goal of the Lilly-Boehringer Ingelheim Diabetes alliance, which is to leverage our combined expertise to develop important treatments for people with diabetes."

In July 2013, the companies announced the marketing authorisation application (MAA) for LY2963016 was accepted for review by the European Medicines Agency (EMA).

In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in the field of diabetes that centers on three compounds representing several of the largest treatment classes. This alliance leverages the companies' strengths as two of the world's leading pharmaceutical companies, combining Boehringer Ingelheim's solid track record of research-driven innovation and Lilly's innovative research, experience, and pioneering history in diabetes. By joining forces, the companies demonstrate commitment in the care of patients with diabetes and stand together to focus on patient needs.

Boehringer Ingelheim Pharmaceuticals, Inc., is the largest US subsidiary of Boehringer Ingelheim Corporation and a member of the Boehringer Ingelheim group of companies which is one of the world's 20 leading pharmaceutical companies.

Lilly, a leading innovation driven corporation, is developing a growing portfolio of pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organisations.