Drug maker Merck has said its experimental pill for people infected with COVID-19 has cut hospital stays and deaths by half, marking a potential leap forward in the global battle against the pandemic.
If it were cleared by regulators, it would be the first pill proven to treat COVID-19.
The company said it would soon be asking health authorities in the U.S. and around the world to approve the pill’s use. A decision by the U.S. Food and Drug Administration could be made within weeks, and the drug, if approved, could be distributed quickly soon thereafter.
A pill taken at home would ease pressure on hospitals and could also help contain outbreaks in poorer and more remote corners of the world who do not have access to the more expensive IV therapies.
Merck and partner Ridgeback Biotherapeutics said initial results showed that patients who received the drug molnupiravir within five days of symptoms of COVID-19 were hospitalized and died about half as often as those who received a dummy pill.
The study tracked 775 adults with mild to moderate COVID-19 who were classified as high risk for serious illness due to health problems such as obesity, diabetes, or heart disease. The results were not verified by outside experts, the standard practice of reviewing new medical research.
7.3 percent of patients taking molnupiravir were either hospitalized or died after 30 days, compared with 14.1 percent of those taking the dummy pill. After that period, there were no deaths among those who received the drug, compared with eight in the placebo group, according to Merck.
The results were so convincing that an independent group of medical experts who monitored the study recommended that it end early.
Company executives said they plan to submit the data to the FDA in the coming days.
COVID vaccines still matter
Experts stressed the continued importance of vaccines in controlling the pandemic as they help prevent transmission and also reduce the severity of the disease in those who become infected.
White House coronavirus coordinator Jeff Zients said vaccinations will remain the government’s main strategy to fight the pandemic. “We want to prevent infections, not just wait to treat them when they arise,” he said.
Dr. Anthony Fauci, the government’s leading authority on infectious diseases, described the Merck results as “very good news.”
Health experts, including Fauci, have long called for a convenient pill patients can take when COVID-19 symptoms first appear.
Merck has only studied its drug in unvaccinated people. However, FDA regulators may consider approving it for wider use in vaccinated patients who experience breakthrough COVID-19 symptoms.
Andrew Pekosz of Johns Hopkins University predicted that vaccines and antiviral drugs would ultimately be used together to protect against the worst effects of COVID-19.
“These should not be viewed as a substitute for vaccination – the two should be viewed as two strategies that can be used together to significantly reduce serious illness,” said Pekosz, a virology specialist.
The US government is committed to buying enough pills to treat 1.7 million people, provided the FDA approves the drug. Merck said it could make pills for 10 million patients by the end of the year and it has contracts with governments around the world.
The results reported on Friday included patients in Latin America, Europe and Africa.