Merck & Co – known as MSD outside the US and Canada – has announced in a European work-sharing procedure (WSP) that an extension to the label for metformin products in the EU has been approved – including Glucophage (metformin hydrochloride HCL immediate release), Glucophage XR (metformin HCL extended release) and Stagid (metformin embonate immediate release).
The decision allows Glucophage to be used as the first oral anti-diabetic medicine safely from conception to birth and addresses an unmet medical need regarding the prevalence of hyperglycaemia. In 2021, 21.1 million births were affected by hyperglycaemia worldwide.
The European Health authorities participating in the WSP analysed the potential risk and benefit factors of metformin when used on both the mother and child, with the decision based on data – taken from Merck’s own safety cohort study CLUE1 and a substantial body of evidence – evaluating metformin in pre-gestational and gestational diabetes.
For the mother, metformin was better than insulin regarding pregnancy weight gain and was also comparable to insulin in reaching maternal blood sugar control.
Read more:
https://www.pmlive.com/pharma_news/mercks_glucophage_approved_in_europe_as_first_oral_diabetic_medication_for_use_during_pregnancy_1388287