The agency said it was issuing this advice “to support national authorities who may decide on possible early use of the medicine prior to marketing authorisation, for example in emergency use settings, in light of rising rates of infection and deaths due to COVID-19 across the EU”.
The most common side effects reported during treatment and within 14 days after the last dose of molnupiravir were diarrhea, nausea, dizziness and headache, all of which were either mild or moderate.
EMA does not recommend the drug for women who are pregnant or breastfeeding. The agency said its comprehensive evaluation of the drug was continuing.
Earlier this month, Britain became the first country to authorise Merck’s COVID-19 pill.
An antiviral pill that reduces symptoms and speeds recovery could prove groundbreaking, easing caseloads on hospitals and helping to curb outbreaks in poorer countries with fragile health systems.
It would also bolster the two-pronged approach to the pandemic: treatment by way of medication, and prevention primarily through vaccinations.
Molnupiravir is also pending review with regulators in the United States and elsewhere.
The US Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinise the pill’s safety and effectiveness in late November.
Initial supplies will be limited.
Merck has said it can produce 10 million treatment courses through the end of the year, but much of that supply has already been purchased by governments worldwide.
EU also reviewing Pfizer’s COVID-19 antiviral pill
The European Union’s drug regulator said it has started evaluating the COVID-19 pill made by Pfizer Inc. to see if it might be used in emergency situations before it is officially authorised.
In a statement on Friday, the European Medicines Agency said it is looking at data on the effectiveness of Pfizer’s antiviral pill when given to people infected with COVID-19 who are not yet hospitalised but are at risk of developing severe disease.
Early results suggest Pfizer’s pill reduces the risk of hospitalisation or death, compared with people who received a dummy pill, when they were treated within three to five days of developing COVID-19 symptoms, the agency said.
Although a more comprehensive evaluation will likely start soon, “this current review will provide EU-wide recommendations in the shortest possible timeframe so they can be used by national authorities who wish to take evidence-based decisions on the early use of the medicine,” the regulator said.
Pfizer said earlier this month that its pill cut the risk of hospitalisation or death by up to 90 per cent.
The company reported few details on side effects but said rates of problems were similar between the groups at about 20 per cent.