Drugmaker Merck has said its experimental pill for people who have COVID-19 has cut hospitalizations and deaths in half, representing a potential leap forward in the global fight against the pandemic.
If cleared by regulators, it would be the first pill proven to treat COVID-19.
The company said it would soon ask health authorities in the U.S. and around the world to approve use of the pill. 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 after.
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 lack access to the more expensive infusion therapies.
Merck and partner Ridgeback Biotherapeutics said initial results showed that patients who received the drug molnupiravir within five days of COVID-19 symptoms were about half as likely to be hospitalized and die as those who received a placebo.
The study followed 775 adults with mild to moderate COVID-19 who were considered at high risk for severe disease because of health problems such as obesity, diabetes, or heart disease. The results were not reviewed by outside experts, the usual process for reviewing new medical research.
Of the patients taking molnupiravir, 7.3% were either hospitalized or died after 30 days, compared with 14.1% of patients receiving the placebo pill. After that period, there were no deaths among those receiving the drug, compared with eight in the placebo group, according to Merck.
The results were so compelling that an independent group of medical experts who monitored the study recommended that it be stopped early.
Company executives said they plan to submit the data to the FDA in the coming days.
Experts stressed the continued 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.
White House coronavirus coordinator Jeff Zients said that vaccination will remain the government’s main strategy for controlling the pandemic. “We want to prevent infections, not just wait to treat them when they happen,” he said.
Dr. Anthony Fauci, the government’s foremost authority on infectious diseases, called the results from Merck “very good news.”
Health experts, including Fauci, have long called for a convenient pill that patients could take when COVID-19 symptoms first appear.
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 breakthrough COVID-19 symptoms.
Andrew Pekosz of Johns Hopkins University predicted vaccines and antiviral drugs would ultimately be used together to protect against the worst effects of COVID-19.
“These shouldn’t be seen as replacements for vaccination — the two should be seen as two strategies that can be used together to significantly reduce severe disease,” said Pekosz, a virology specialist.
The U.S. government has committed to purchasing enough pills to treat 1.7 million people, assuming the FDA authorises the drug. Merck said it can produce pills for 10 million patients by the end of the year and has contracts with governments worldwide.
The results reported Friday included patients across Latin America, Europe and Africa.