Merck COVID pill is effective, experts will review safety

Federal health regulators say that an experimental COVID-19 pill from Merck is effective against the virus, but they will seek advice from outside experts on the risks of birth defects and other potential problems during pregnancy.

The U.S. Food and Drug Administration released an analysis of the pill before a public meeting held next week. Academia and other experts will weigh its safety and effectiveness at the meeting. The agency does not need to follow the organization’s recommendations.

FDA scientists stated that their review identified several potential risks, including possible toxicity and birth defects. In light of these risks, the FDA will ask its advisors whether the drug should not be used during pregnancy or whether it can be provided under certain circumstances.

In this case, the FDA stated that the drug will carry warnings about risks during pregnancy, but in some cases, if the benefits may outweigh the risks to the patient, doctors can still choose to prescribe it.

Taking into account safety issues, the FDA said that Merck agreed that the drug will not be used in children.

In addition, the FDA expressed concern that Merck’s drug will cause small changes in the characteristic spike protein of the coronavirus, which is used to penetrate human cells. In theory, the FDA warned that these changes could lead to dangerous new variants.

The regulator also pointed out that the overall safety data collected by Merck on its drugs is far less than data collected by other COVID-19 therapies.

The FDA will ask its independent consultants to discuss all these issues and then vote on whether the overall benefits of the drug outweigh its risks.

All COVID-19 drugs currently authorized by the FDA require injection or intravenous injection and can only be given by health professionals. If approved, Merck’s drug will become the first drug that can relieve symptoms and accelerate recovery for American patients at home.It has been authorized for emergency use in the UK

This meeting marked the first public review of a new drug for COVID-19 by a regulatory agency, reflecting strong interest and review of a pill that may soon be used by millions of Americans.

It has been proven that this drug monelavir can significantly reduce the hospitalization rate and mortality of patients with mild to moderate coronavirus infections.

Merck’s drug uses a new method to fight COVID-19: It inserts tiny mutations into the genetic code of the coronavirus, making it unable to replicate itself.

But this genetic effect has raised concerns that in rare cases, this drug may cause birth defects or tumors.

Pregnant women were excluded from Merck’s study. Both women and men in the study were asked to use contraception or abstinence.

Merck said that the company’s two rodent studies showed that “molnupiravir does not cause DNA mutations or damage in these animal models.” The company said that rodents are longer than humans taking the drug. Received a higher dose within the period of time.

FDA reviewers also confirmed that Merck’s previously reported interim results indicate that the pill will reduce the hospitalization rate and mortality of patients with early symptoms of COVID-19 who are at a higher risk due to health problems by about half.

However, on Friday morning Merck announced the updated results of the same study, which showed that the benefit of the drug was small.

In a company study of more than 1,400 adults, molnupiravir reduced the combined risk of hospitalization and death by 30%, lower than the 50% originally reported based on incomplete results.

Nearly 7% of patients who received Merck drug treatment within five days of the onset of COVID-19 symptoms were eventually admitted to the hospital, and one of them died. In contrast, 10% of hospitalized patients took a placebo and 9 people died.

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