FDA approved Merck pills as a second easy-to-use drug against COVID-19

 

US adds Merck pills as a second easy-to-use drug against COVID-19.

 On Thursday, US health regulators allowed the second anti-CO. pill to be taken

VID-19, providing another easy-to-use drug to fight the rising tide of Omicron infection. The FDA's announcement of Merck's molonopiravir comes a day after the agency gave up a competing drug from Pfizer.

Due to their superior benefits and moderate side effects, Pfizer's pills, Paxlovid, are likely to become the first choice for treatment against the virus.

As a result, Merck's tablets are expected to have a lesser role against the pandemic than was expected just a few weeks ago. Its ability to avoid severe COVID-19 is much lower than initially announced, and the drug label will warn of severe safety issues, including the potential for congenital disabilities.

Both treatments will be accessible to patients in the United States after the federal government has purchased them.

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

The agency said that Molnopiravir should be considered for patients "who are inaccessible to FDA-authorized alternative treatment options for COVID-19 or are not clinically appropriate." This limitation did not include Paxlovid, licensed for patients 12 years of age and older.

Molnupiravir, which Merck and Ridgeback Biotherapeutics make, will also carry a warning against use during pregnancy. The FDA said that women of childbearing age should use contraception during treatment and a few days afterward, while men should use contraception for at least three months after the final dose. The federal agency also said that molnopiravir should not be used in patients under 18 years of age because it may affect bone growth.

Nick Kartsonis, senior vice president of clinical research at Merck, said the company's scientists are still studying the drug and hope to gain approval for it for use in children eventually.

The restrictions were expected after an advisory panel from the Food and Drug Administration endorsed the drug last month, warning that its use should be strictly tailored to patients who could benefit most.

Kartsonis said the Merck researchers are "very comfortable" with the drug's safety profile.

He also noted that molnopiravir had been studied by more than a thousand people. Research has seen side effects such as diarrhea and nausea in only a tiny percentage of patients.

"The drug seemed to be well-tolerated, in fact," he said.

Paxlovid from Pfizer also comes with limitations. Regulators say clinicians should consider how it interacts with other medications a patient may be taking and note that it should not be prescribed to patients with severe liver or kidney problems.

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

Hacking works differently, and Pfizer does not take the same risks. In addition, Pfizer was nearly three times more effective in the test, reducing hospitalizations and death by almost 90% among high-risk patients, compared with 30% for Merck.

Some experts question whether Merck will have a significant role in the United States.

"To the extent that there is a large supply of Pfizer pills, I think it will not be used," said Dr. Gregory Poland of the Mayo Clinic, referring to Merck. "There would be no reason, given its lower efficacy and higher risk of side effects."

For now, the FDA's decision offers another potential option against the virus that has killed more than 800,000 Americans, even as health officials prepare for record cases, hospitalizations, and deaths driven by the omicron variable.

According to data from Johns Hopkins University, the seven-day rolling average of COVID-19 cases in the United States rose to more than 160,000 on Wednesday. This is more than double the average in late November.

Antiviral pills such as Merck's and Pfizer's are expected to be effective against omicron because they do not target the thorny protein where most of the variant's worrisome mutations are located.

Researchers have warned that older, IV-administered COVID-19 treatments are unlikely to work against the new strain.