Merck Announces U.S. FDA Filing Acceptance of New Drug Application (NDA) for MK-1293, an Investigational Follow-On Biologic Insulin Glargine; Marketing Authorization Application to the European Medicines Agency Currently Under Review
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The development program for MK-1293 was designed to meet rigorous regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality. In addition to Phase 1 studies assessing its pharmacokinetic and pharmacodynamic properties, the NDA submission for MK-1293 includes results of two Phase 3 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.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. Separately, the Marketing Authorization Application for MK-1293, which Merck submitted to the European Medicines Agency in December 2015, is currently under review.
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