London — On Thursday (Nov 4), Britain became the first country in the world to approve Merck’s Covid-19 antiviral pill, which can be used on people with mild to moderate Covid-19 infection.
Known as Lagevrio in Britain, the drug Molnupiravir was jointly developed by United States-based Merck & Co Inc and Ridgeback Biotherapeutics.
It was recommended by Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) to be administered on those mild to moderate Covid-19 and at least one risk factor for developing severe illness such as older age diabetes, heart disease and obesity.
The drug, offered in capsule form, is given as soon as possible after a confirmed Covid-19 positive test and within five days of the onset of symptoms, said MHRA.
With the drug administration’s approval, Molnupiravir is the first approved oral antiviral treatment for Covid-19 and the first for a Covid-19 drug to be used within the community, reported Reuters.
On Nov 30, the US Antimicrobial Drugs Advisory Committee will meet to review the drug’s safety and efficacy data and vote on Molnupiravir’s authorisation.
The drug was designed to introduce errors in the genetic code of the coronavirus strains that cause Covid-19. It is taken twice a day for five days.
Although similar drugs in the same category have been shown to cause birth defects in animal studies, Molnupiravir animal testing is said to be safe. The official data on the findings have not yet been published.
According to Merck in a CNN report, the capsule reduced the risk of hospitalization or death from the virus by 50 per cent.
“At the interim analysis, Molnupiravir reduced the risk of hospitalization or death by approximately 50 per cent; 7.3 per cent of patients who received Molnupiravir were either hospitalized or died through day 29 following randomization (28/385), compared with 14.1 per cent of placebo-treated patients (53,377),” said Merck in a news release in October.
“Through day 29, no deaths were reported in patients who received Molnupiravir, as compared to eight deaths in patients who received placebo.”
Former commissioner of the US Food and Drug Administration said, “This is the most impactful result that I remember seeing of an orally available drug in the treatment of a respiratory pathogen, perhaps ever.”
“I think getting an oral pill that can inhibit viral replication — that can inhibit this virus — is going to be a real game-changer,” he told CNN.
UK vaccines minister Maggie Throup told parliament that efforts are being made across the government and the National Health Service in England to “urgently get this treatment to patients initially through a national study so we can collect more data on how antivirals work in a mostly vaccinated population.” /TISG
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