FDA to Review Follow-on Biologic Insulin Glargine Candidate
The Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for MK-1293 (Merck), a follow-on biologic insulin glargine candidate, for the treatment of type 1 and type 2 diabetes.
The NDA submission was supported by data from Phase 1 pharmacokinetic and pharmacodynamic studies, as well as, from two Phase 3 studies comparing MK-1293 to Lantus, the originator insulin glargine, in patients with type 1 diabetes and in type 2 diabetes. These studies were designed to meet rigorous regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality.
Merck filed the NDA through the 505(b)(2) regulatory pathway, allowing the FDA to reference previous safety and efficacy data for an already-approved product (Lantus), in addition to review of study results for MK-1293.
MK-1293 is being developed by Merck with partial funding from Samsung Bioepis.
For more information call (800) 672-6372 or visit Merck.com.