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Merck’s Covid pill secures narrow backing from US executive

US government advisers have narrowly recommended that doctors be allowed to prescribe Merck’s antiviral drug to high-risk patients, paving the way for the emergency authorization of a new drug. treatment for Covid-19 amid concerns about Omicron variant and recent increase in infectious diseases.

Medical experts on the U.S. Food and Drug Administration voted 13 to 10 on Tuesday to give the green light to the drug molnupiravir, which trials have shown can reduce it by nearly one one-third risk of severe illness and death from Covid-19. in unvaccinated people.

However, the advisors say the easy-to-implement treatment should only be recommended for high-risk patients 18 years of age and older with mild to moderate symptoms. The committee called for strict restrictions on use in pregnant women because of concerns about potential side effects.

US authorities are not required to follow the recommendation from the Antimicrobial Drugs Advisory Committee, but most experts expect the FDA to quickly approve the drug because of concerns about Omicron – a new coronavirus variant. is spreading rapidly in southern Africa.

UK and EU regulators, which are also battling a new wave of infections ahead of winter, granted emergency use authorization for molnupiravir earlier this month.

For several hours on Tuesday, committee members debated whether the drug’s modest benefits outweigh its potential safety risks.

Last week Merck said the treatment is ineffective than it thought.

A review of early data from a large trial of the drug showed it reduced hospital admissions by nearly 50% compared with placebo – prompting Merck to pause the study and seek urgent authorization. But that number dropped to about 30% after the final analysis of the trial.

“I voted yes, but this is clearly a very difficult decision,” said Michael Green, a member of the advisory committee and professor at the University of Pittsburgh.

The only Covid-19 treatments approved outside of hospitals in the United States are monoclonal antibodies developed by Regeneron, Eli Lilly, and GlaxoSmithKline, which are usually given through an intravenous infusion.

With FDA approval, doctors will be able to prescribe the 5-day Merck antiviral to take at home. However, experts have noted that the treatment must be given within days of contracting Covid-19 for it to be effective.

Earlier, on Tuesday, Regeneron warned preliminary testing showed its treatment would be less effective in people infected with the Omicron variant. Moderna, the vaccine maker, also guess that existing spearheads will be less effective against the new strain.

Green said he voted to recommend Merck’s drug due to “lack of availability of an alternative therapy for those at high risk, perhaps including the potential and loss of efficacy of monoclonal drugs with appearance of variations”.

Concern about whether existing vaccines and therapies will combat this variant has led some medical experts to predict that pills like Merck’s will play a key role in treating this variant. Omicron infections.

Pfizer has also applied for emergency use authorization for its rival antiviral drug, which reduced hospitalizations and deaths by 90% in a large trial of high-risk adults with Covid-19 .

Unlike vaccines and monoclonal antibodies, Merck’s oral tablet does not target the virus’s spike protein. Instead, it tries to trick the virus into using the wrong building blocks, resulting in mutations that cause it to form a weak chain. Pfizer’s pill blocks an enzyme that Covid-19 needs to replicate.

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