LY 2963016 filed with FDA for Type 1 &2 Diabetes - Eli Lilly/Boehringer

Eli Lilly and Boehringer announced that the FDA has accepted the filing of the New Drug Application (NDA) for LY 2963016, an investigational basal (long-acting) insulin for the treatment of patients with Type 1 and 2 Diabetes. The NDA was filed through the 505(b) 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 LY 2963016.

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 2 Diabetes, using a currently marketed insulin glargine product as the active comparator. The companies announced the marketing authorisation application (MAA) for LY 2963016 was accepted for review by the European Medicines Agency (EMA) in July 2013.