5 August 2016 - Marketing authorization application to the European Medicines Agency currently under review.

Merck today announced that the U.S. FDA has accepted for review the new drug application for MK-1293, an investigational follow-on biologic insulin glargine candidate for the treatment of people with type 1 and type 2 diabetes, which is being developed by Merck with partial funding from Samsung Bioepis.

“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,” said Peter Stein, M.D., vice president, late stage development, diabetes and endocrinology, Merck. “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.”

Read Merck press release