The United Kingdom has become the first country in the world to approve a potentially game-changing COVID-19 antiviral pill jointly developed by Merck and Ridgeback Biotherapeutics.
The Medicines and Healthcare products Regulatory Agency (MHRA) recommended on Thursday that the drug, molnupiravir, be used as soon as possible following a positive COVID-19 test and within five days of the onset of symptoms, citing clinical data.
This is the first oral antiviral treatment for COVID-19 to be approved, marking a boost to the fight against the pandemic, with the green light coming before potential regulatory clearance in the United States. US advisers will meet this month to vote on whether molnupiravir should be authorised.
Treatments to tackle the pandemic, which has killed more than 5.2 million people worldwide, have so far 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.
Merck’s 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, to be branded Lagevrio in the UK, 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.
Molnupiravir is also being studied in a late-stage trial for preventing infection.
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.
UK ‘working at pace’ to deploy drug
The UK government and the country’s National Health Service (NHS) will confirm how the treatment will be deployed to patients in “due course”.
Last month, authorities agreed a deal with Merck to secure 480,000 courses of molnupiravir.
“We are working at pace across the government and with the NHS to set out plans to deploy molnupiravir to patients through a national study as soon as possible,” Health Secretary Sajid Javid said in a statement shared on Twitter on Thursday.
The speedy approval in the UK came as the government struggles to tame soaring infections.
The country has about 40,000 daily cases of COVID-19, according to the latest seven-day average. That total is second only to the roughly 74,000 a day in the US, which has five times more people.
Data released on Wednesday night showed COVID-19 prevalence in England hit its highest level on record last month, led by a high numbers of cases in children and a surge in the southwest of the country.
Pressure is growing on the government to implement its “Plan B” aimed at protecting the NHS from unsustainable demands, involving mask mandates, vaccine passes and work-from-home orders.