EU regulator recommends Merck’s COVID-19 pill for emergency use

The European Union’s medicines watchdog has advised its member states they can use a potentially groundbreaking COVID-19 antiviral pill in emergency situations triggered by soaring infection rates, ahead of the treatment’s formal approval across the bloc.

Molnupiravir, which is produced by Merck and Ridgeback Biotherapeutics, can be given within five days of first symptoms to treat adults who do not need oxygen support and are at risk of severe disease, 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 keen to deploy the pill, to be branded Lagevrio in Europe, ahead of it gaining full authoristation from the regulator “in light of rising rates of infection and deaths due to COVID-19 across the EU”.

Coronavirus rates are currently spiralling in several European countries, including Germany, the Netherlands, Austria and Hungary, leading governments fearing a difficult winter ahead to reimpose virus restrictions.

Molnupiravir has been closely watched since data last month showed it could halve the chances of dying or being hospitalised for those most at risk of developing severe COVID-19 when given early in the illness.

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 done so far has shown it is effective against all variants of the coronavirus, Merck has said, including the highly infectious Delta strain.

The EMA’s decision came after former EU member state the United Kingdom became the first country in the world to greenlight molnupiravir for use earlier in November.

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) recommended at the time that the drug be used as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, citing clinical data.

Merck has also sought approval for the pill to be used in the United States. The US Food and Drug Administration is expected to deliver a decision on that imminently.

Treatments to tackle the pandemic, which has killed more than five million people worldwide, have until now focused mainly on vaccines.

Other options, including Gilead’s infused antiviral remdesivir and generic steroid dexamethasone, are generally only given after a patient has been hospitalised.