The US has approved the Merck pill at home as a second treatment for COVID-19

By Manas Mishra and Carl O’Donnell

(Reuters) – The US banned Merck & Co’s COVID-19 anti-virus pill on Thursday for some high-risk adult patients, giving broader approval for a similar but more effective treatment and a day later https://www.reuters. com / business / healthcare-pharmaceuticals / pfizer-says-covid-19-pill-near-90-effective-final-analysis-2021-12-14 Pfizer Inc. (NYSE 🙂

The U.S. Food and Drug Administration said Merck’s drug could be used when other authorized treatments are not available or clinically appropriate.

Drug, molnupiravir https://www.reuters.com/business/healthcare-pharmaceuticals/merck-says-its-covid-19-drug-should-be-effective-against-any-variant-2021-11-30, Ridgeback It was developed with Biotherapeutics and was shown to reduce hospitalizations and deaths by about 30% in a clinical trial of high-risk individuals at the onset of the disease.

Permission allows you to use mild and moderate COVID-19 and Pfizer with the pill https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-oral-covid-19-pill-gets- us-authorization-at-home -use-2021-12-22 may be an important tool against the rapidly spreading Omicron variant, which is currently prevalent in the United States.

Pfizerren drug, Paxlovid https://www.reuters.com/business/healthcare-pharmaceuticals/us-govt-buy-10-mln-courses-pfizers-covid-19-pill-529-bln-2021-11-18, it was authorized on Wednesday for people 12 years of age and older and has been shown to be nearly 90% effective in preventing hospitalizations and deaths of patients at high risk for serious illness, according to the trial data.

The FDA says some patients should avoid Pfizer’s two-drug regimen because it includes an older antiviral called ritonavir, which is known to interact with other prescription drugs. It is also not recommended for people with severe kidney problems.

Merck plans to ship hundreds of thousands of treatment courses in the coming days and a million in the coming weeks. Pfizer expects to ship about 250,000 courses next month.

The availability of other treatments is a major concern for physicians considering prescribing Merck’s treatment, according to Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.

The FDA has approved intravenous treatments, mostly for hospitals, called monoclonal antibodies, but their availability is limited and their effectiveness against the Omicron variant is lower.

FDA official John Farley told a news conference that GlaxoSmithKline (NYSE 🙂 and Vir Biotech’s antibody, which has been shown to work against Omicron, will be scarce in the winter.

Merck said the treatment had advantages over the Pfizer pill.

“It doesn’t need a second drug to increase its effectiveness, and you can give it to a variety of special patient populations, including people with severe liver or kidney function problems,” said Nick Kartsonis, Merck’s vice president of the clinic. research into vaccines and infectious diseases, he told Reuters.

“This acceptance comes at the right time, as more COVID-19 treatments are needed to complete the vaccination effort, especially considering variants of concern,” said Fitzgerald analyst Louise Chen Cantor.

Nearly 62% of people in the United States are fully vaccinated, leaving many Americans unprotected from a wave of Omicron infection. Two doses of the highly successful vaccine from Pfizer Inc and BioNTech SE (NASDAQ) only protect against Omicron variant infection, while a third dose enhances the immune response.

Both Merck’s and Pfizer’s antivirals work to prevent the virus from recurring. Merck’s pill works by inserting errors in the virus’s genetic code.

Some FDA experts say this could lead to more problematic variants.

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

Therefore, Merck’s drug is not permitted for use in patients under 18 years of age, the FDA said. The pill is not recommended for use during pregnancy, the agency added.

The agency recommended that men of childbearing potential use a reliable method of birth control in their treatment with molnupiravira, and for at least three months after the last dose.

The drug should be taken twice a day – four pills at a time – for five days, with a full treatment of 40 pills. The cost of treatment was about $ 700 per course in a $ 5 million deal with the U.S. government.

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

Merck says molnupiravir, which helps prevent virus replication, must be effective against any variant, including the new Omicron variant.