FDA advisory committee recommends emergency authorization of Merck’s C…

A U.S. Food and Drug Administration (FDA) advisory committee recommended emergency use authorization of Merck & Co’s experimental pill to treat mild-to-moderate COVID-19 patients on Tuesday.

The drug, called molnupiravir, stops the virus from making copies of itself, which prevents it from spreading throughout the body.   

Recent trial data have shown that it can reduce the risk of death or being hospitalized for those at high risk of harsh Covid by 30 percent.

On Tuesday, the Antimicrobial Drugs Advisory Committee (AMDAC) voted 13-10In favor of the drug.

The FDA is not bound to follow the advisory group’s recommendations but the agency rarely goes against the guidance of the group. 

If empowered by the FDA and signed off by the Centers for Disease Control and Prevention (CDC), Merck’s drug could be the first oral antiviral medication for COVID-19 – and could allow patients to take the drug at home instead of requiring them to go to a hospital for treatment.

An FDA advisory committee voted in favor of emergency use authorization of Merck & Co’s pill to treat mild-to-moderate COVID-19 patients. Pictured: Merck’s experimental COVID-19 treatment pill called molnupiravir

Molnupiravir is an antiviral drug that was developed at Emory University, in Atlanta, by its drug innovation company, Drug Innovation Ventures at Emory (excursion), which was licensed by Ridgeback Biotherapeutics LP, that partnered with Merck.

It was originally meant to treat influenza and prevents the virus from making copies of itself by creating errors during viral RNA replication.

Animal studies conducted last year found molnupiravir could completely suppress viral transmission and prevent and reduce harsh lung damage.

In an initial examination, the study tracked 775 adults with mild-to-moderate COVID-19 who were considered higher risk for harsh illness due to health problems such as obesity, diabetes or heart disease.

Among patients taking molnupiravir, 7.3 percent were either hospitalized or died at the end of 30 days, compared with 14.1 percent of those getting the dummy pill.

There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck.

However, the final examination was published on Friday ahead of the FDA advisory committee meeting, included more than 1,400 participants.

The participants were divided into two groups, one of which received the drug and the other was given a placebo.

Researchers found that 9.7 percent of the control group suffered a harsh enough case to require hospitalization or cause death – compared to only 6.8 percent of the control group, for a reduction of 30 percent. 

This is a breaking news story and will be updated.

Daily Mail Online

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