FDA to Review Follow-on Biologic Insulin Glargine Candidate

The NDA is supported by one Phase 1 trial, and two seperate Phase 3 trials
The NDA is supported by one Phase 1 trial, and two seperate Phase 3 trials

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. 

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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.

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