Advice precedes formal approval of a potentially groundbreaking antiviral drug as infections skyrocket.
The European Union’s drug watchdog has advised its member states to use a potentially groundbreaking antiviral antiviral pill against COVID-19 in emergency situations caused by rising infection rates, ahead of formal block-wide approval of the treatment.
Molnupiravir, produced by Merck and Ridgeback Biotherapeutics, can be given within five days of the first symptoms to treat adults who do not require oxygen support and are at risk for serious illness, the European Medicines Agency (EMA) said in a statement on Friday.
The EMA said it had issued its advice to support national authorities who may be interested in using the Pill, under the name Lagevrio in Europe, before it receives full authorization from the regulator “in light of the rising infection rates and deaths from COVID-19. -19 across the EU”.
The number of coronaviruses is currently on the rise in several European countries, including Germany, the Netherlands, Austria and Hungary, leading governments to fear a difficult winter ahead to re-impose virus restrictions.
Molnupiravir has been closely watched since data last month showed it could cut the risk of death or hospitalization in half for those most at risk of developing severe COVID-19 when given early in the disease.
The drug is designed to introduce errors into the genetic code of the virus that causes COVID-19 and is taken twice a day for five days.
Viral sequencing performed to date has shown it to be effective against all variants of the coronavirus, Merck said, including the highly contagious strain Delta.
The EMA’s decision came after the former EU member state, the United Kingdom, became the first country in the world to authorize the use of molnupiravir earlier in November.
At the time, the UK’s Medicines and Healthcare Products Regulatory Authority (MHRA) advised using the drug as soon as possible after a positive COVID-19 test and within five days of the onset of symptoms, citing clinical data.
Merck has also sought approval for the use of the Pill in the United States. The US Food and Drug Administration is expected to make a decision soon.
Treatments to tackle the pandemic, which has killed more than five million people worldwide, have so far focused on vaccines.
Other options, including Gilead’s infused antiviral remdesivir and generic steroid dexamethasone, are generally only given after a patient is hospitalized.