MK 1293 (insulin glargine biosimilar) filed with FDA for treatment of type 1 and type 2 diabetes- Merck Inc

The FDA has accepted for review the New Drug Application (NDA) for MK 1293 (insulin glargine biosimilar) for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck Inc. In addition to Phase I studies assessing its pharmacokinetic and pharmacodynamic properties, the NDA submission for MK-1293 includes results of two Phase III studies , one conducted in people with type 1 diabetes, and one in people with type 2 diabetes; Lantus (insulin glargine), the originator insulin glargine, was the active comparator in both studies.

Separately, the Marketing Authorization Application for MK 1293, which Merck submitted to the European Medicines Agency in December 2015, is currently under review. The NDA was filed through the 505(b)(2) regulatory pathway, which allows the FDA to reference previous findings of safety and efficacy for an already-approved product (Lantus), in addition to reviewing findings from studies of MK-1293.