US adds Merck tablets as second easy-to-use COVID-19 drug

On Thursday, U.S. regulators authorized the release of a second COVID-19 pill, providing another easy-to-use drug to fight the growing wave of omicron infections.

The FDA’s announcement for Merck’s molnupiravir comes a day after the agency cleared a competing drug from Pfizer.

Pfizer’s Paxlawid tablets are likely to be the first choice against the virus due to its superior benefits and milder side effects.

As a result, Merck tablets are expected to play a smaller role in the fight against the pandemic than predicted just a few weeks ago. Its ability to prevent severe COVID-19 disease is far less than originally stated, and the drug’s label warns of serious safety issues, including the possibility of birth defects.

Both treatments will be free to patients in the US once purchased by the federal government.

The FDA has approved Merck for adults with positive COVID-19 test results, early symptoms, and those at highest risk of hospitalization, including the elderly and those with medical conditions such as obesity and heart disease.

The agency said molnupiravir should be considered for patients “for whom FDA-approved alternative COVID-19 treatment options are not available or clinically unacceptable.” It did not include the paxloid restriction, which was allowed for patients 12 years and older.

Molnupiravir, manufactured by Merck and Ridgeback Biotherapeutics, also contains a warning against use during pregnancy. The FDA has said that women of childbearing age must use contraception during and for several days after treatment, and men must use contraception for at least three months after their last dose. The federal agency also said that molnupiravir should not be used in patients under the age of 18 because it may affect bone growth.

Dr. Nick Kartsonis, Merck’s senior vice president of clinical research, said the company’s scientists are still studying the drug and hope it will eventually be approved for use in children.

The restrictions were expected after an FDA advisory panel only narrowly approved the drug last month, warning that its use must be strictly tailored to patients who may benefit the most.

Kartsonis said the Merck researchers are “very happy” with the safety profile of their drug.

He also noted that molnupiravir has been studied in more than a thousand people, and studies have shown that side effects such as diarrhea and nausea are observed in only a small percentage of patients.

“The drug actually looked very well tolerated,” he said.

Pfizer’s paxlawid also has limitations. Regulators say doctors should consider how it will interact with other medications a patient may be taking and noted that it should not be prescribed to patients with severe liver or kidney problems.

Both treatments should also be started within five days of the onset of symptoms, a deadline that makes patients quickly get tested and diagnosed.

The two pills work in different ways, and Pfizer does not share the same risks. In addition, Pfizer was about three times more effective in testing, reducing hospitalizations and deaths by nearly 90% in high-risk patients, compared with 30% for Merck.

Some experts doubt that Merck’s drug will play a large role in the US.

“Since there is a sufficient supply of Pfizer tablets, I think they will not be used,” said Dr. Gregory Poland of the Mayo Clinic, referring to Merck. “There would be no reason given the lower efficacy and higher risk of side effects.”

For now, the FDA ruling provides another potential option against the virus that has killed more than 800,000 Americans, even as health officials prepare for record-breaking cases, hospitalizations, and deaths caused by the omicron variant.

The seven-day moving average for COVID-19 cases in the U.S. surpassed 160,000 on Wednesday, according to data compiled by Johns Hopkins University. This is more than double the average at the end of November.

Antiviral pills like Merck’s and Pfizer are expected to be effective against omicron because they do not target the spike protein, which contains most of the variant’s alarming mutations.

The researchers warned that the old treatments for COVID-19, which are administered intravenously, are unlikely to work against the new strain.

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The FDA based its decision on Merck’s decision on results showing that nearly 7% of patients taking the drug ended up in hospital and one died after 30 days. This is compared with 10% of hospitalized patients who took placebo and nine deaths.

Merck says there will be several hundred thousand treatments available in the US in the next few days, and a million in the next few weeks. Pfizer’s drug supply will be more limited until an increase in 2022.

The US will pay about $ 700 for each course of Merck’s drug, which requires patients to take four tablets twice a day for five days. According to a survey by Harvard University and King’s College London, each 40-pill course of treatment costs about $ 18.

Merck’s drug introduces tiny errors in the coronavirus’s genetic code to slow it down. This genetic effect has raised concerns that the drug could cause mutations in human fetuses and even cause more virulent strains of the virus to emerge. But FDA scientists said the variant risk is largely theoretical because people take the drug for such a short period of time.

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