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The European Union’s medicines agency on Monday began reviewing Merck’s COVID-19 treatment pill so that it can swiftly advise national drug authorities in the 27-nation bloc that want to begin using it before it gets official approval.
The European Medicines Agency said in a statement that it will give “EU-wide recommendations in the shortest possible timeframe to help national authorities decide on possible early use of the medicine, for example, in emergency use settings.”
The Amsterdam-based agency will give the recommendations while a comprehensive review of molnupiravir continues ahead of a possible application to market the drug.
Currently most COVID-19 treatments require an IV or injection. Merck’s COVID-19 pill is already under review by the U.S. Food and Drug Administration after showing strong initial results. On Thursday, the United Kingdom became the first country to OK it.
In the UK, the pill was approved for adults 18 and older who have tested positive for COVID-19 and have at least one risk factor for developing severe disease, such as obesity or heart disease. Patients with mild-to-moderate COVID-19 would take four pills of the drug twice a day for five days.
In the United States, the FDA has set a public meeting later this month to review molnupiravir. The company reported in September that its drug slashed rates of hospitalization and death by 50%.
The drug targets an enzyme the coronavirus uses to reproduce itself, inserting errors into its genetic code that slow its ability to spread and take over human cells. That genetic activity has led some independent experts to question whether the drug could potentially cause mutations leading to birth defects or tumors.