First oral diabetes treatment approved in Europe for use during pregnancy

In a European work-sharing procedure (WSP), Glucophage was approved as the first oral anti-diabetic medication to be used safely from conception to birth

Merck announced in a European work-sharing procedure (WSP) an extension to the label for metformin products in the EU – Glucophage(metformin hydrochloride [HCL] immediate release), Glucophage XR (metformin HCL extended-release) and Stagid (metformin embonate immediate release) - for use throughout pregnancy.

Maria Rivas, SVP and Chief Medical Officer at Merck said, “During pregnancy and when wanting to become pregnant, good glycemic control is of utmost importance, as insufficient glycemic control leads to a three times higher risk of pregnancy loss than in normoglycemic women. The estimated risk of malformation is doubled. Until now, pregnant women were required to use insulin to control their blood sugar during this period. The label extension now opens a tablet alternative to women who are not able or wanting to use daily injections.”

In a European work-sharing procedure (WSP), the variation for label extension was approved based on results from Merck’s register-based cohort safety study, investigating the follow up of children from over 4.000 pregnancies with metforminfor up to 11 years and extensive independent scientific publications, which all confirmed no increased risk of congenital abnormalities or feto/neonatal toxicity after exposure to metformin at the time of conception and throughout pregnancy.