Merck: Pill cuts COVID-19 hospitalizations, deaths
Company will ask US, other nations to OK use
WASHINGTON – Drugmaker Merck said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus, potentially a leap forward in the global fight against the pandemic.
The company said it will soon ask health officials in the U.S. and around the world to authorize the pill’s use. A decision from the U.S. Food and Drug Administration could come within weeks after that, and the drug, if approved, could be distributed quickly soon afterward.
If cleared, it would be the first pill shown to treat COVID-19. All other therapies now authorized in the U.S. require an IV or injection. A pill taken at home would ease pressure on hospitals and could also help curb outbreaks in poorer and more remote corners of the world that don’t have access to the more expensive infusion therapies.
“This would allow us to treat many more people, much more quickly and, we trust, much less expensively,” said Dr. William Schaffner, an infectious diseven ease expert at Vanderbilt University, who was not involved in the research.
Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a placebo pill. The study tracked 775 adults with mild to moderate COVID-19 who were considered at higher risk for severe disease due to health problems such as obesity, diabetes or heart disease. The results have not been peer reviewed by outside experts, the usual procedure for vetting new medical research. Among patients taking molnupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those getting the placebo. There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck.
An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong. That is typical when early results show so clearly that a treatment works that there is no need for further testing before applying for authorization.
Company executives said they plan to submit the data for review by the FDA in coming days.
with the news of a potentially effective new treatment for COVID-19, experts stressed the importance of vaccines for controlling the pandemic, given that they help prevent transmission and also reduce the severity of illness in those who do get infected.
“We love having more treatments available, but prevention is the first goal,” Schaffner said. “Vaccination continues to be the foundation of how we can get ahead of COVID.”
White House coronavirus coordinator Jeff Zients said that vaccination will remain the government’s main strategy for controlling the pandemic.
Dr. Anthony Fauci, the government’s foremost authority on infectious diseases, called the results from Merck “very good news.”
And effective therapies will be critical given that billions of people around the world remain unvaccinated.
“It exceeded what I thought the drug might be able to do in this clinical trial,” said Dr. Dean Li, vice president of Merck Research Laboratories. “When you see a 50% reduction in hospitalization or death, that’s a substantial clinical impact.”
Merck only studied its drug in people who were not vaccinated. But FDA regulators may consider authorizing it for broader use in vaccinated patients who get COVID-19 symptoms.