The U.K.’s medicines regulator has approved the world’s first pill designed to treat symptomatic Covid-19, the British government announced on Thursday.
Developed by Ridgeback Biotherapeutics and Merck Sharp & Dohme, the antiviral medication, molnupiravir, was found to be “safe and effective” at reducing the risk of hospitalization and death in people with mild to moderate Covid-19 who are at heightened risk of developing severe disease, the government said.
Britain’s Medicines and Healthcare products Regulatory Agency has approved the pill, which will be called Lagevrio in the U.K., for use for those who have a mild to moderate case of the disease, and at least one risk factor for developing serious illness, including older age, obesity, diabetes mellitus or heart disease.
The pill’s approval makes it the first oral antiviral Covid-19 medication in the world to get the green light, the British government said.
In a statement published online, British health secretary Sajid Javid said the approval marked a “historic day for our country, as the U.K. is now the first country in the world to approve an antiviral that can be taken at home for Covid-19.”
“This will be a gamechanger for the most vulnerable and the immunosuppressed,” Javid said.
The health secretary said the British government was “working at pace” with the U.K.’s National Health Service to deploy the antiviral medication to patients through a national study “as soon as possible.”
“This antiviral will be an excellent addition to our armoury against Covid-19,” he said, adding that it still “remains vital everyone comes forward for their life-saving Covid-19 vaccine,” as well as for booster shots.
How does it work?
Lagevrio has been found to work in symptomatic cases by interfering with the Covid-19 virus’s replication, the British government said.
By preventing the virus from multiplying, the medication helps keep virus levels in the body low, reducing the severity and impact of the disease.
Clinical trial data suggests that the medication is most effective when administered during the early stages of infection.
As a result, Britain’s medicines regulator is recommending patients take it as soon as possible following a positive Covid-19 test and within five days of the onset of symptoms.
The pill’s approval comes amid widespread concerns in the U.K. over high rates of Covid-19, with Britain seeing tens of thousands of cases confirmed each day.
On Wednesday alone, more than 40,800 new cases were identified, with the daily death toll reaching 217, according to Johns Hopkins University’s Covid-19 tracker. The seven-day average for the week was at 39,216 and 163 deaths per day.
British Prime Minister Boris Johnson has so far resisted calls to implement a “Plan B” approach that would see the return of mask mandates and social distancing following his government’s lifting of restrictions in England in July.