The UK’s Medicines Regulatory Authority has granted first permission for Merck’s antiviral pill for Covid-19, a drug that public health experts have hailed as an important new tool to fight the pandemic.
Merck said Thursday that the Drug and Health Care Regulatory Agency has granted clearance for the drug under the brand Lagevrio for mild to moderate COVID symptoms.
It marks the first green light for molnupiravir, an easy-to-use oral treatment that cuts the risk of hospitalization or death in half for people with mild to moderate Covid-19 during clinical trials.
Regulators in the United States and the European Union are still evaluating Merck, which has attracted increased requests from governments since positive results from a phase 3 study were published last month.
The UK has purchased nearly half a million cycles of molnupiravir, while the US has ordered 1.7 million cycles of the drug at a total cost of $1.2 million, which is worth about $700 per cycle.
Merck said last week that it expects molnopiravir to generate up to $7 billion in global revenue by the end of next year.
Robert Davis, Merck’s CEO, said the first global authorization of molnopiravir was a major achievement for the company.
“In pursuit of Merck’s steadfast mission to save and improve lives, we will continue to act with determination and urgency to bring molnopiravir to patients around the world as quickly as possible,” he said.
Health experts have welcomed the development of an antiviral tablet to treat Covid-19 that can be taken at home within five days of infection to prevent the onset of serious illness. Merck’s pills are allowed for use by people who have mild to moderate symptoms of Covid-19 and who have at least one risk factor that makes them susceptible to severe illness.
So far, the only approved treatments for mild to moderate Covid-19 are expensive monoclonal antibodies developed by Regeneron, Eli Lilly and GlaxoSmithKline, which are usually given by intravenous injection.
David Dowdy, associate professor of epidemiology at Johns Hopkins University School of Medicine in Baltimore, said licensing molnopiravir is a welcome advance that could save lives in the fight against COVID-19.
But he cautioned that the antiviral pill isn’t an ideal treatment because it only offered a 50 percent reduction in hospitalization and death, and people had to receive the drug early enough for it to be effective.
“Since the drug doesn’t stop the infection, I’m not sure I’d go any further than to describe it as a game-changer the way vaccines were,” Doody said.
FDA advisors are scheduled to consider whether to grant emergency use authorization for molnupiravir at a meeting later this month.
Merck has halted a phase 3 clinical trial of the drug on the advice of an independent panel of scientists monitoring the trial and consultations with the U.S. Food and Drug Administration (FDA) due to the extremely positive results.
Merck said an interim analysis of data from 775 patients showed that none of the participants who received molonopiravir died within the first 29 days of the study, versus eight who received a placebo.