FDA accepts new drug application for biologic insulin glargine

The FDA has accepted a new drug application for MK-1293, an investigational follow-on biologic insulin glargine candidate for adults with type 1 and type 2 diabetes, Merck announced in a press release.

“The FDA acceptance of our follow-on biologic application is an important milestone, and brings us closer to offering another treatment option for people in the U.S. with diabetes,” Peter Stein, MD, vice president, late stage development, diabetes and endocrinology, Merck, said in the statement. “We are proud of the significant contributions we have already made to helping people with type 2 diabetes, and with investigational MK-1293, we hope to expand our portfolio into insulin therapeutics and treatments for people with type 1 diabetes.”

Samsung Bioepis is providing partial funding for development of the drug, a biosimilar to insulin glargine injection (Lantus), the originator insulin glargine.

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 the results of two phase 3 studies, one conducted in people with type 1 diabetes and one in people with type 2 diabetes; insulin glargine was the active comparator in both studies.

The new drug application was filed through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act. A 505(b)(2) application was submitted that relied, in part, on the FDA’s finding of safety and effectiveness for insulin glargine injection to support approval, as well as 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.