The European Union’s drug regulator on Friday advised that an experimental COVID-19 pill from Merck should be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of their disease worsening.
The European Medicines Agency (EMA) said the pill, developed along with Ridgeback Biotherapeutics, should be taken twice a day for five days, but advised against use during pregnancy for in women who plan to get pregnant.
“EMA issued this advice to support national authorities who may decide on possible early use of the medicine prior to marketing authorisation ... in light of rising rates of infection and deaths due to COVID-19 across the EU,” it said.
EMA began a rolling review of the Merck tablet, Lagevrio, last month, and on Friday also started looking at data on a rival pill from Pfizer Inc. to make recommendations on its use, like that for Merck’s, before wider approvals.
The regulator on Friday also said that breastfeeding must also be stopped around the time of treatment with Merck’s Lagevrio.
