Merck KGaA's Glucophage the first oral anti-diabetic approved in EU for use in pregnancy

In a European worksharing procedure (WSP), Germany’s Merck KGaA (MRK: DE) Glucophage (metformin hydrochloride) and its immediate and extended-release versions have been approved as the first oral anti-diabetic medication to be used safely during pregnancy.

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 more than 4,000 pregnancies with metformin for 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.

"The label extension now opens a tablet alternative to women who are not able or wanting to use daily injections"Maria Rivas, senior vice president 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.”