The Food and Drug Administration’s license for Merck’s molnupiravir comes a day after the agency removed a competing drug from Pfizer. That oral pill, Paxlovid, will likely become the first-choice treatment against the virus, thanks to its superior benefits and milder side effects.
As a result, Merck’s pill is expected to have a smaller role in fighting the pandemic than predicted just a few weeks ago. Its ability to fight severe COVID-19 is much lower than originally claimed, and the label will warn of serious safety issues, including the potential for birth defects.
The Food and Drug Administration has authorized Merck’s for adults with early symptoms of COVID-19, who face the highest risk of hospitalization, including the elderly and those with diseases such as obesity and heart disease. The UK first authorized the drug in early November.
Called molnupiravir, Merck comes with a warning not to use it during pregnancy. The FDA says women of childbearing age should use birth control during treatment and for several days afterward, while men should use birth control for at least three months after their last dose.
The restrictions were expected after an FDA advisory panel approved the drug only last month, warning that its use would have to be strictly regulated for patients who could benefit. Most.
Pfizer tablets work differently and do not carry the same risks. Additionally, Pfizer’s drug was three times as effective in the trial, reducing hospitalization and mortality by nearly 90% in high-risk patients, compared with Merck’s 30%.
Some experts question whether there are multiple roles for Merck in the US
Dr. Gregory Poland at the Mayo Clinic, referring to the drug Merck said: “Given the ample supply of Pfizer, I don’t think it will be used. “There would be no excuse, as it has less effectiveness and a higher risk of side effects.”
Now, the FDA’s decision offers another potential option to fight the virus that has killed more than 800,000 Americans, even as health officials brace for record-setting cases, hospitalizations and deaths. death caused by the omicron variant. Antivirals, including Merck’s, are believed to be effective against omicrons because they do not target the mutant protein that is home to most of the variant’s worrisome mutations.
The FDA made its decision based on results that showed that nearly 7% of patients taking the drug were hospitalized and one died after 30 days. This compares with 10% of hospitalized patients receiving placebo and 9 deaths.
Federal officials have agreed to buy enough of the drug to treat 3.1 million people.
The US will pay about $700 for each course of Merck’s drug, which requires patients to take four pills twice a day for five days. A review by Harvard University and King’s College London estimated the cost to be around $18 per course of 40 tablets.
Merck’s drug inserts tiny errors into the coronavirus’ genetic code to slow its reproduction. That genetic effect has raised concerns that the drug could induce mutations in human fetuses and even promote more virulent strains of the virus. But the FDA scientists say the risk of variation is largely theoretical because people take the drug for such a short period of time.
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https://abc13.com/covid-pill-merck-fda-for-molnupiravir/11375974/ Merck antiviral oral tablet: FDA authorizes second easy-to-use drug against COVID, could help reduce omicron rise