First antiviral pill for COVID-19 — developed in Atlanta — could receive FDA authorization

Nearly two years into the pandemic, the FDA could soon authorize the first antiviral pill, offering an at-home COVID-19 treatment designed to keep high-risk adults out of the hospital.

Dr. Richard Plemper, Ph.D., Professor in the Institute for Biomedical Sciences at Georgia State University, whose team worked with Emory University researchers to develop molnupiravir, says the pill blocks the SARS-CoV-2 virus from replicating and taking over the body.

Merck and Ridgeback Biotherapeutics say the pill lowered the risk of hospitalizations and deaths in high-risk study volunteers if given within 5 days of the first signs of infection.

"The treatment would be started immediately after, for example, a positive PCR test," Plemper says.  "That means even before the onset of clinical signs. That gives the patient the most, the greatest chance for therapeutic benefit."

Last month, an FDA advisory panel voted 13 to 10 to recommend the agency authorize molnupiravir for individuals such as seniors and those with underlying health conditions that could raise their risk of becoming severely ill from the virus.


The FDA is expected to make its final decision on the pill soon.

"The initial patient group will be elderly, so adults 60 to 65 years of age and higher, with at least one additional risk factor," Plemper explains.

Once a person tests positive for COVID-19, Plemper says, they could call their doctor, who could then call in a prescription for molnupiravir.

The treatment involves taking 40 pills over the course of 5 days.

Pfizer Pharmaceuticals has also developed its own COVID-19 antiviral pill it says lowers the risk of hospitalization and death by 85%.

Both treatments appear to be effective against the emerging omicron variant.

Still, Plemper cautions, the best protection is to get vaccinated and boosted.

"But, I think we also have to have the therapeutic option for those who cannot be vaccinated, for those who don't respond well to the vaccine, for those who, for different reasons, may not be prepared to take the vaccine," he says.