Merck’s Covid pill Lagevrio secures green light from UK regulator

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 and Healthcare products Regulatory Agency had granted authorisation for the drug under the brand name Lagevrio for people with mild to moderate Covid and have at least one risk factor for developing severe illness.

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 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 $1.2bn, which works out to about $700 per course.

Last week Merck, which co-developed the antiviral pill with Ridgeback Biotherapeutics, said it expected molnupiravir to generate up to $7bn in global revenue by the end of next year.

Chief executive Robert Davis 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 that can be taken at home within five days of infection to prevent the onset of serious disease.

So far, the only treatments approved for mild to moderate Covid are expensive monoclonal antibodies developed by Regeneron, Eli Lilly and GlaxoSmithKline, which are typically given intravenously.

David Dowdy, associate professor of epidemiology at Johns Hopkins University School of Medicine in Baltimore, said the authorisation of molnupiravir could save lives in the fight against Covid.

But he cautioned that the pill was not a perfect cure given that it only provided a 50 per cent reduction in hospitalisation and death during the trials 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.

UK health authorities stressed the drug should not be used as a substitute for vaccination.

June Raine, head of the UK’s Medicines and Healthcare Products Regulatory Agency, said the drug was another “therapeutic to add to our armoury against Covid-19”.

“It is also the world’s first approved antiviral for this disease that can be taken by mouth rather than administered intravenously,” she added. “This is important because it means it can be administered outside of a hospital setting, before Covid-19 has progressed to a severe stage.

“With no compromises on quality, safety and effectiveness, the public can trust that the MHRA has conducted a robust and thorough assessment of the data.”