FDA Panel Endorses Emergency Use Authorization of Merck's COVID-19 Pill, Molnupiravir

On Tuesday, a US Food and Drug Administration (FDA) advisory group recommended that Merck & Co's experimental pill for treating mild-to-moderate COVID-19 patients be approved for emergency use.

The treatment, known as molnupiravir, prevents the virus from replicating, stopping it from spreading throughout the body. According to recent study results, it can lower the probability of mortality or hospitalization for patients at high risk of severe COVID-19 by 30%.

Merck's COVID-19 pill seeks approval from FDA, CDC

The Antimicrobial Drugs Advisory Committee (AMDAC) voted in favor of the medicine 13-10 on Tuesday. The FDA is not obliged to accept the advisory group's recommendations, but it rarely does.

Merck's medicine, if approved by the FDA and the Centers for Disease Control and Prevention (CDC), might be the first oral antiviral medication for COVID-19, allowing patients to take the drug at home rather than having to go to the hospital for treatment.

According the Daily Mail, molnupiravir is an antiviral drug created at Emory University in Atlanta by its drug development business, Drug Innovation Ventures at Emory (DRIVE), and licensed by Ridgeback Biotherapeutics LP, a Merck-affiliated company.

It was developed to treat influenza and works by causing flaws in viral RNA replication, preventing the virus from reproducing itself. Molnupiravir was discovered to entirely inhibit viral transmission and prevent and decrease severe lung damage in animals in trials conducted last year.

The study followed 775 persons with mild-to-moderate COVID-19 who were at a higher risk of severe illness due to health issues such as obesity, diabetes, or heart disease in an initial analysis. At the end of 30 days, 7.3 percent of individuals receiving molnupiravir were hospitalized or died, compared to 14.1 percent of those taking the dummy pill, indicating that the danger is cut in half.

The final analysis, which was released on Friday ahead of the FDA advisory committee meeting, drew almost 1,400 people. The subjects were divided into two groups, with one receiving the medicine and the other a placebo.

Molnuparivir reduces COVID-19 deaths, hospitalization rates

Researchers discovered that 9.7% of the control group had a severe case of COVID-19 that required hospitalization or resulted in death, compared to only 6.8% of the control group, a 30% reduction.

While Merck and its partner Ridgeback Biotherapeutics were the first to submit their COVID-19 pill to the FDA, Pfizer isn't far behind, with its own medication in the works.
Pfizer's medicine is a protease inhibitor, a type of antiviral pill that has been used to treat HIV and hepatitis C for decades. They are not the same as Merck's pill.

The alterations in the omicron form should not impair Pfizer's medicine, according to the company. If the medicine is approved, the US government has promised to buy 10 million treatment courses from Pfizer. That's more than three times the government's molnupiravir purchasing agreement with Merck, which is for 3.1 million courses. Patients must take numerous pills twice a day for five days with both medications, as per News12.

As Omicron spreads over the world, Dr. Anthony Fauci predicts that the global case tally will "change rapidly," NY Post reported. The latest COVID-19 variant has already demonstrated it spreads quickly, according to the White House chief medical adviser, by sweeping all of the provinces in South Africa, where it was originally found by experts last week before spreading overseas.

However, the senior doctor cautioned that learning more about the variant, which has about 50 mutations, the majority of which are in its spike protein, the portion of the virus that connects to human cells, will take weeks. In terms of the current COVID-19 vaccinations' ability to confer immunity against the variant, Fauci believes it is "reasonable" to think that the current doses will still provide some protection.

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FDA, Merck