US and EU regulators are still evaluating Merck’s drug, which has attracted a surge of orders from governments since positive results from its phase 3 study were published last month © Lakshmi Prasad/Alamy
The UK medicines regulator has granted the first authorisation to Merck’s antiviral pill for Covid-19, a drug that has been hailed by public health experts as an important new tool to combat the pandemic.
Merck said on Thursday the Medicines & Healthcare Products Regulatory Agency had granted authorisation for the drug under the trademark Lagevrio to mild-to-moderate Covid symptoms.
It marks the first green light for molnupiravir, an easy-to administer-oral treatment that halved the risk of hospitalisation or death for people with mild to moderate Covid-19 during clinical trials.
US and EU regulators are still evaluating Merck’s drug, which has attracted a surge of orders from governments since positive results from its phase 3 study were published last month.
The UK has purchased almost half a million courses of molnupiravir, while the US has ordered 1.7m courses of the drug at a total cost of $1.2m, which works out at about $700 per course.
Last week Merck said it expects molnupiravir to generate up to $7.bn in global revenue by the end of next year.
Robert Davis, Merck chief executive, said the first global authorisation of molnupiravir was a major achievement for the company.
“In pursuit of Merck’s unwavering mission to save and improve lives, we will continue to move with both rigour and urgency to bring molnupiravir to patients around the world as quickly as possible,” he said.
Health experts have welcomed the development of an antiviral pill to treat Covid-19 that can be taken at home within five days of infection to prevent the onset of serious disease. Merck’s pill is authorised for use by people who have mild-to-moderate Covid-19 symptoms and have at least one risk factor that makes them vulnerable to developing severe disease.
So far, the only treatments approved for mild-to-moderate Covid-19 are expensive monoclonal antibodies developed by Regeneron, Eli Lilly and GlaxoSmithKline, which are typically given via intravenous infusions.
David Dowdy, associate professor of epidemiology at John Hopkins university School of medicine in Baltimore, said the authorisation of molnupiravir is a welcome advance that could save lives in the fight against Covid-19.
But he cautioned that the antiviral pill isn’t a perfect cure given it only provided a 50 per cent reduction in hospitalisation and death and people had to receive the drug early enough for it to be effective.
“Since the drug doesn’t stop infection I’m not sure I’d go so far as calling it a game-changer in the way the vaccines have been,” said Dowdy.
Advisers to the US Food and Drug Administration are due to consider whether to grant an emergency use authorisation for molnupiravir at a meeting later this month.
Merck halted phase 3 clinical trials of the drug following advice from an independent committee of scientists monitoring the trial and consultations with the FDA due to very positive results.
The interim analysis of data from 775 patients showed that none of the participants receiving molnupiravir had died during the first 29 days of the study, versus eight who received a placebo, Merck said.