Pharmaceutical company Merck announced Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus.
The company said it would soon ask health officials in the U.S. and around the world to authorize its use.
Merck’s drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic.
Merk says 7.3% of patients who received the medicine, called molnupiravir, in an interim analysis were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients.
The trial for the pill looked at non-hospitalized adult patients with laboratory-confirmed mild to moderate COVID-19 who had at least one risk factor associated with poor disease outcomes and their symptoms started within five days of the randomization.
Merck says Molnupiravir is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of the COVID-19 virus. It’s been shown to be “active” in several preclinical models of the virus, including for prophylaxis, treatment, and prevention of transmission, according to Merk. The company says the pill has also been shown to be “active” against the most common variants.
The study was conducted globally, including in more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom, and the U.S.
The most common risk factors for poor disease outcome included obesity, older age, diabetes mellitus, and heart disease, according to Merk.
An independent group of medical advisers monitoring the trial recommended stopping it early because the interim results were so strong.
However, the study results were released by the company and have not been peer-reviewed.
“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. 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,” said Merk’s CEO and president, Robert M. Davis, in a statement.
During a White House COVID-19 response team briefing, Dr. Anthony Fauci the news of the pill's efficacy is promising and the data is impressive.
"There was a 50% diminution of importance, is that in the placebo group there were eight deaths and in the treatment group, there were no deaths. That’s also very important and very good news," said Fauci.
As for when it could get FDA approval, Fauci said public health officials hesitate to make any timelines.
"The FDA will look at the data and in their usual, very efficient and effective way, will examine the data as quickly as they possibly can and then it will be taken from there. Because once a recommendation is made, we go through the same process of getting its recommendation for its usage through the CDC," said Fauci.
White House COVID-19 response coordinator Jeff Zients said the federal government has contracted to purchase 1.7 million doses of the Merck medicine to make the therapy available, but there's also an option for additional doses.
"If approved, I think the right way to think about this is, this is a potential additional tool in our toolbox to protect people from the worst outcomes of COVID," said Zients. "But I think it’s really important to remember that vaccination remains far and away our best tool against COVID-19. It can prevent you from getting COVID in the first place and we want to prevent infections, not just wait to treat them once they happen.