First oral diabetes treatment approved in Europe for use during pregnancy

pharmafile | March 1, 2022 | News story | Manufacturing and Production  

Merck has announced an extension to the label for metformin products in the EU – glucophage (metformin hydrochloride immediate release), glucophage (metformin HCL extended release), and stagid (metformin embonate immediate release) – for use throughout pregnancy.

The variation for label extension was approved based on results from Merck’s register-based cohort safety study, which investigated the follow up of children from over 4,000 pregnanies, with metformin for up to 11 years, and extensive independent scientific publications. These all confirmed no increased risk of congenital abnormalities or feto/neonatal toxicity following exposure to metformin at the time of conception and throughout pregnancy.

Type 2 diabetes is growing increasingly prevalent around the world. In 2021, 21.1 million births worldwide (16.7%) were affected by hyperglycaemia. Using metformin during pregnancy is comparable to insulin in reaching maternal blood sugar control, and isbetter than insulin regarding pregnancy weight gain, according to European Health authorities.

When combined with insulin for pregestational diabetes, metformin lessens the amount of insulin required and lowers the risk of severe hypoglycaemia.

Maria Rivas, SVP and CMO at Merck shared, “During pregnancy and when wanting to become pregnant, good glycaemic control is of utmost importance, as insufficient glycaemic 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.”

Lina Adams

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