AMSTERDAM – The European Medicines Agency has issued emergency use advice for Merck's COVID-19 pill, even though the oral medicine has not yet been authorized.
The Amsterdam-based European Union regulator said the antiviral pill, known as molnupiravir, can be used to treat adults infected with the coronavirus who don't yet need extra oxygen and are at increased risk of developing severe disease.
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The agency said in a statement that the drug should be given as soon as possible after COVID-19 has been diagnosed and within five days of symptoms starting. It is intended to be taken twice a day for five days.
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 authorization, 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.
Europe is currently battling a deadly resurgence of COVID-19, with Germany's disease control chief declaring Friday that “all of Germany is one big outbreak.”
Earlier this month, Britain became the first country to authorize 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 U.S. Food and Drug Administration announced last month it would convene a panel of independent experts to scrutinize 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.