WASHINGTON – Drugmaker Merck said on Friday that its experimental COVID-19 pill cut hospitalizations and deaths among people recently infected with the coronavirus by half, potentially a leap forward in the global fight against the pandemic.
The company said it would soon ask health officials in the US and around the world to authorize the use of the pill. A decision from the US Food and Drug Administration could come within weeks after that, and the drug, if OK, could be distributed sooner rather than later.
If approved, it would be the first pill to be shown to treat COVID-19. All other treatments now authorized in the US require an IV or injection. Conversely, a pill taken at home would ease pressure on hospitals and could help contain outbreaks in poorer and more remote corners of the world, which do not have access to more expensive infusion therapy.
“This will allow us to treat many more people, much more quickly and, we believe, much less expensive,” said Dr. William Schaffner, an infectious disease specialist at Vanderbilt University.
Merck and its partner Ridgeback Biotherapeutics said early results show that patients who received the drug, called mollupiravir, had the same rates of hospitalization and death within five days of COVID-19 symptoms as those patients. There were about half of those who had received the dummy pill. The study tracked 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 have not been reviewed by outside experts, the usual procedure for reviewing new medical research.
Of the patients taking molanupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those taking the dummy pill. According to Merck, there were no deaths in the drug group after that time period, compared to eight deaths in the placebo group.
An independent group of medical experts overseeing the trial recommended stopping it early because the interim results were so strong. This is typical when preliminary results show so clearly that a treatment works that there is no need for further testing before applying for authorization. Company officials said they plan to submit the data for review by the FDA in the coming days.
Even with news of a potentially effective new treatment for COVID-19, experts stressed the importance of vaccines to control the pandemic, noting that they help prevent transmission and prevent infection. It also reduces the severity of the disease in people.
“We would love to have more treatments available, but prevention is the first goal,” Schaffner said. “Vaccination remains the cornerstone of how we can overtake COVID.”
Still, effective treatments will be important, given that billions of people worldwide live without vaccinations.
“What I thought was what I might be able to do in this clinical trial,” said Dr. Dean Lee, vice president of Merck Research Laboratories. “It’s a significant clinical effect when you see a 50% reduction in hospitalizations or deaths.”
Merck studied its drug only in people who had not been vaccinated. But FDA regulators may consider authorizing it for wider use in vaccinated patients who get COVID-19 symptoms.
Patients take eight tablets daily for five days. Side effects were reported by both groups in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.
Results from an earlier study showed that the drug did not benefit patients who were already hospitalized with serious illness.
The US has approved remdesivir, an antiviral drug specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus. But all drugs have to be given by IV or injection into hospitals or medical clinics, and the latest surge of the Delta version has spurred supplies.
Health experts, including America’s top infectious disease expert Dr. Anthony Fauci, have long called for a convenient pill that patients can take when symptoms of COVID-19 first appear, just like the standard flu medicine. Tamiflu helps fight influenza. Such drugs are seen as the key to controlling future waves of infection and mitigating the impact of the pandemic.
Merck’s pill works by interfering with the ability of the coronavirus to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.
The US government has committed to purchase 1.7 million doses of the drug if authorized by the FDA. Merck has said it can produce 10 million doses by the end of the year and has contracts with governments around the world. The company has not announced the prices.
Several other companies, including Pfizer and Roche, are studying similar drugs that could report results in the coming weeks and months.
Merck had planned to enroll more than 1,500 patients in its final phase trial before the independent board stopped it early. The results reported on Friday included patients enrolled in Latin America, Europe and Africa. Executives estimate that about 10% of the patients studied were from the US
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