Eli Lilly and Company (NYSE: LLY) and Boehringer Ingelheim today announced that the U.S. 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 U.S. 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).
Eli Lilly and Company; Boehringer Ingelheim