US approves second home remedy for COVID-19

On December 23, the United States approved the release of Merck & Co (MRK.N) antiviral pills for the treatment of COVID-19. They are intended for certain high-risk adult patients. This is the second drug that can be taken at home. The day before Pfizer Inc COVID-19 Treatment Pills Approved (PFE.N). Writes about it Reuters.

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The US Food and Drug Administration (FDA) has said the drug can be used when other approved treatments are not available or clinically unacceptable.

Molnupiravir was co-developed with Ridgeback Biotherapeutics and has been shown to reduce hospital admissions and deaths by about 30% in clinical trials involving early-stage high-risk individuals.

The approval allows the drug to be used to treat mild to moderate COVID-19 and, along with the Pfizer pill, could be an important tool against the rapidly spreading omicron variant that now dominates the United States.

Pfizer Paxlovir was approved on December 22nd for people aged 12 and older, according to trial data. It has been shown to be nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness.

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The FDA says some patients should avoid the Pfizer regimen because it includes the older antiviral drug ritonavir, which is known to interact with some other drugs. It is not recommended for people with severe kidney disease.

Merck plans to send hundreds of thousands of treatments in the coming days and 1 million over the next few weeks. Pfizer expects to ship about 250 courses next month.

The FDA has approved intravenous treatment mainly in hospitals. It uses monoclonal antibodies, but the availability of this treatment is limited and the efficacy against the omicron variant is lower.

FDA spokesman John Farley said a shortage of antibodies from GlaxoSmithKline (GSK.L) and Vir Biotech (VIR.O), both of which have been shown to work against omicron, are expected this winter.

Merck said its treatment has advantages over Pfizer tablets.

“No second drug is required to make it more effective, and you can give it to a variety of special patient populations, including people who have serious problems with liver or kidney function,” said Nick Cartsonis, senior vice president at Merck.

“This approval comes at the right time as more drugs are needed to treat COVID-19,” said Cantor Fitzgerald analyst Louise Chen.

Almost 62% of people in the United States are fully vaccinated, but many Americans remain unprotected from the omicron wave. Two doses of the vaccine only partially protect against infection with the new strain, while the third dose improves the immune response.

Both Merck and Pfizer antiviruses prevent the virus from replicating. The Merck pill does this by introducing errors into the genetic code of the virus.

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Some experts at the FDA have said this could lead to more problematic new strains.

There have also been concerns about the safety of the drug, as it can affect bone cartilage and growth.

For this reason, Merck is not approved for use in patients under the age of 18. The tablet is not recommended for use during pregnancy.

The FDA has advised men of reproductive potential to use reliable birth control during treatment with molnupiravir and for at least three months after the last dose.

The drug is designed to be taken twice a day, four tablets for five days, which is 40 tablets for the full course of treatment. The treatment costs about $700 per course under a deal with the US government that includes up to 5 million courses.

The US government has ordered 10 million courses of Pfizer at $ 530 per course, compared to a deal with Merck for 5 million courses of molnupiravir at $ 700 per course.

Merck said molnupiravir, which helps prevent viral replication, should be effective against any variant, including omicron.

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