Merck
- Merck and Ridgeback plan to apply for FDA authorization for their COVID-19 pill "as soon as possible."
- The companies said the drug, molnupiravir, halved the risk of hospitalization or death in a trial.
- If authorized, it would be the first approved antiviral pill designed specifically to treat COVID-19.
- See more stories on Insider's business page.
A COVID-19 pill developed by Merck and Ridgeback Biotherapeutics halved the likelihood of death or hospitalization from the virus in a study, interim results show.
The companies said Friday morning that they would apply for emergency authorization from the Food and Drug Administration (FDA) "as soon as possible," adding that they had stopped recruitment into their study early "due to these positive results." They would also seek authorization from regulators around the world, they said.
If they get authorization, their drug, molnupiravir, would be the first antiviral pill on the market designed specifically to treat COVID-19 patients.
The phase-three trial involved 775 at-risk, non-hospitalized adult patients with "mild-to-moderate" COVID-19. An interim analysis found the drug "significantly reduced the risk of hospitalization or death," the companies said.
They said that 7.3% of patients who received molnupiravir were either hospitalized or died within 29 days, compared with 14.1% of placebo-treated patients.
Nobody who received molnupiravir died, compared to eight deaths among patients who received placebo, the companies said.
All participants in the trial had at least one risk factor that made it more likely they'd develop a severe case of COVID-19, such as obesity, health disease, and old age, the companies said.
Merck and Ridgeback said that molnupiravir reduced the risk of hospitalization and death across all underlying risk factors, and that it had "consistent efficacy" across the Delta, Gamma, and Mu variants of the coronavirus. Delta has become the dominant strain in the US.
The federal government agreed to buy enough molnupiravir pills to treat 1.7 million people in a $1.2 billion deal in June, though it said that this was dependent on the drug getting FDA emergency-use authorization.
Merck stock was up 7.1% in pre-market trading at 7.40 a.m. ET.