Merck says COVID-19 pill cuts risks in half, will seek emergency authorization
Pharmaceutical company Merck on Friday said it will seek an emergency authorization for its oral antiviral COVID-19 treatment after the medicine was shown to reduce the risk of hospitalization by 50 percent during clinical trials.
An analysis of phase three trials found that 7.3 percent of patients treated with Merck’s drug, called molnupiravir, were hospitalized within 29 days, according to the company’s Friday statement. Of the study participants who received a placebo, 14.1 percent were hospitalized or died by the last day of the trial. No deaths were reported in patients who were given molnupiravir during the duration of the trial, while eight deaths were reported in those who were treated with placebos.
The drug was also proven to be consistently effective against all strains of COVID-19, including the highly contagious delta variant.
A pill to effectively treat COVID-19 has long been a major goal, and the new results quickly won praise from experts.
“This is a phenomenal result, I mean this is a profound game-changer to have an oral pill that had this kind of effect,” former Food and Drug Administration (FDA) Commissioner Scott Gottlieb said on CNBC.
Every participant in the study was unvaccinated and had at least one underlying health condition that increased their chances of developing a more serious case of COVID-19. Some of the most common health factors among participants included obesity, diabetes, heart disease and being over the age of 60.
The trial was conducted at more than 170 sites in countries including the United States, the United Kingdom, Japan, Taiwan and South Africa.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most,” Robert M. Davis, CEO and president of Merck, said in a statement. “Consistent with Merck’s unwavering commitment to save and improve lives, we will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible.”
The company said it plans to submit an application for emergency use authorization to the FDA as soon as possible based on the trial’s results. If granted the authorization, molnupiravir could be the first oral antiviral treatment for COVID-19, Merck’s statement noted.
Merck said it plans to produce 10 million courses of the drug by the end of 2021, with additional doses expected to be produced in 2022.
The news follows comments from Merck earlier this week saying that molnupiravir had demonstrated in lab studies to likely be effective against COVID-19 variants.
Peter Sullivan contributed to this report, which was updated at 8:03 a.m.