Merck To Seek Emergency Use Authorization From The FDA For COVID Antiviral Drug

Friday, October 1st 2021, 4:46 pm
By: Erica Rankin

Merck announced positive results from its phase 3 study of its oral antiviral pill, molnupiravir.

The company announced the pill reduced the risk of hospitalization and death by approximately 50% when given to non-hospitalized adult patients that had a mild to moderate case of the COVID-19.

Doctors said if an EUA is granted for molnupiravir, it will be a game changer and it would make it the first oral antiviral medicine for COVID-19. 

"We could do this easily as an outpatient and that is very exciting for us,” said Dr. Mary Clarke, president of the Oklahoma State Medical Association. 

She said right now, the only treatments they have are IVs like monoclonal antibodies. The trouble with those is they are labor intensive and hard to give at urgent cares or primary care offices, especially in rural parts of the state. 

"Yes, the infusion works very, very well and we will continue to use it as we need to,” said Clarke. “But really, it is going to hinge on outpatient treatment you can readily get."

Merck's trial data shows that molnupiravir cut the chance of being hospitalized or dying in from COVID-19 in half. 

All patients in the trial were required to have a laboratory-confirmed, mild-to-moderate COVID-19 case, with symptom onset within five days of study randomization, and have at least one risk factor associated with poor disease outcome. 

Results showing 7.3% of patients who received molnupiravir were hospitalized, compared to the 14.1% of placebo-treated patients who were hospitalized. Eight people in the placebo group died. 

"We would write them a prescription and send them to the pharmacy as long as the pharmacy carries it, and they can start it that day,” said Clarke. 

Then, it would be taken for five days. 

Clarke said if authorization is granted, she's ready to have another tool to help her patients. 

Clarke said she estimates that we could see an FDA authorization by the end of the year.