The United States FDA Authorizes Merck's COVID Pill.
The Food and Drug Administration gave the green light to molnupiravir, a tablet for adults with symptoms and risk of hospitalization. The decision came a day after Pfizer's drug approval.
US health regulators on Thursday authorized the second pill against COVID-19, developed by Merck, which is another easy-to-use drug to combat the growing wave of omicron infections.
The Food and Drug Administration ( FDA ) clearance comes a day after the agency gave the go-ahead to a Pfizer competitor drug. Thanks to its superior benefits and milder side effects, this pill is likely to become the first-line treatment for the virus.
As a result, the Merck pill is expected to play a lesser role against the pandemic than was anticipated a few weeks ago. In addition, its ability to cope with severe COVID-19 is much lower than initially announced, and the drug label will warn of safety concerns such as the possibility of congenital disability.
The Food and Drug Administration (FDA) has authorized Merck's drug for adults with early symptoms of COVID-19 who face the highest risks of hospitalization, including the elderly and those with conditions such as obesity and disease. Cardiac. The UK first allowed the pill in early November.
Known as molonoperavir, Merck will issue a warning against use during pregnancy. According to the FDA, women who are able to have children should use birth control during and after treatment for a few days, while men should use birth control for at least three months after the last dose. ۔
The restrictions were expected after an FDA advisory group narrowly approved the drug last month, warning that its use would have to be tailored strictly to the patients who stand to benefit the most.
Pfizer tablets work differently and do not have the same risks. In addition, Pfizer's drug was nearly three times more effective in tests, reducing hospital admissions and deaths by about 90% in high-risk patients, compared to 30% in Merck's drug.
Some experts wonder if Merck's drug will play a significant role in the United States.
"As long as there is an adequate supply of Pfizer pills, I don't think it will be used," said Dr. Gregory Poland of the Mayo Clinic, referring to Merck's medicine. "There is no reason because it is less effective and has a higher risk of side effects."
Federal authorities have agreed to buy enough medicine to treat 3.1 million people.
The United States will pay about ً 700 for each course of Merck medicine, which requires patients to take four tablets twice a day for five days. A study by Harvard University and King's College London estimates that it costs about ً 18 to treat every 40 pills.
The Merck drug introduces minor errors in the genetic code of the coronavirus to stop its reproduction. That genetic effect has raised concerns that the medicine could cause mutations in human fetuses and even stimulate more virulent strains of the virus. But FDA scientists said the risk of variants is theoretical mainly because people take the drug briefly.
For now, the FDA's decision provides another potential option against the virus that has killed more than 800,000 Americans, even as health authorities brace for a record number of cases, hospitalizations, and deaths driven by the omicron variant. Antiviral pills, including those from Merck, are expected to be effective against omicron because they do not target the spike protein, where most of the worrying mutations of the variant reside.
The FDA based its decision on results that showed that nearly 7% of patients taking the drug ended up in the hospital, and one died within 30 days. This compares with 10% of hospitalized patients taking the placebo and nine deaths.