The pill, said to reduce hospitalizations and deaths, could be a ‘major step forward,’ says Dr. James Cutrell of UT Southwestern.
By Alejandra Canales and Tom Huang
Merck announced Friday morning that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus. The company will ask U.S. and global health officials to authorize its use, The Associated Press reported.
Here’s what doctors and health experts say about this development.
What did Merck’s early results show?
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 dummy pill, AP reported. 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.
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 dummy pill, AP reported. There were no deaths in the drug group after that period compared with eight deaths in the placebo group, according to Merck. This drug also shows efficacy against multiple variants, including delta, gamma and mu. The study has not been published or peer-reviewed.
“I think it will translate into many thousands of lives being saved worldwide, where there’s less access to monoclonal antibodies, and in this country, too,” Dr. Robert Shafer, an infectious disease specialist and expert on antiviral therapy at Stanford University, told The New York Times.
“I think if the results are confirmed, it really is an exciting advance because this would be the first oral antiviral drug that will have been identified to be effective at preventing progression of COVID-19,” Dr. James Cutrell, an associate professor of medicine in the division of infectious diseases at UT Southwestern, told The Dallas Morning News.
“I think this would be a really important tool in our toolbox to use, because once people develop COVID-19, really, our goal is to keep them out of the hospital,” Cutrell said. “An oral medication that can be started early and keep people from progressing to the point of death or hospitalization, that would be a major step forward in terms of preserving capacity.”
Erin Carlson, director of graduate public health programs at the University of Texas at Arlington, said she’s hopeful that by reducing the severity of illness, Merck’s pill could reduce the recovery time for patients and reduce the level of disability that a person incurs from having had COVID-19.
She emphasized that this development does not change the need for people to get vaccinated “to prevent the disease from ever happening, or at least prevent the severe disease from ever happening. We always choose to prevent rather than treat [disease] when we have the option.”
Cutrell said Merck indicates it has entered into nonexclusive voluntary licensing agreements with generic manufacturers. He said that’s an important step that would allow the company to partner with those manufacturers and low- and middle-income countries to scale up production.
How will patients use the pill?
Patients take the pill twice a day for five days to complete a course of treatment. Earlier study results showed the drug did not benefit patients who were already hospitalized with severe disease, AP reported.
The New York Times reported that the pill’s efficacy was lower than that of monoclonal antibody treatments, which mimic antibodies that the immune system generates naturally when fighting the virus. Those drugs have been in high demand, but they are expensive, are typically given intravenously, and have proved labor-intensive for hospitals and clinics to administer.
Here are a few things we know about monoclonal antibody treatments, including those produced by Regeneron and Eli Lilly, based on reporting by Alejandra Canales of The News.
What’s next?
Merck executives said they plan to submit the data to the Food and Drug Administration in the coming days. The FDA could make a decision within weeks — and, if approved, the drug could be on the market soon after, AP reported.
The U.S. government has committed to buy 1.7 million doses of the drug if it is authorized by the FDA. Merck has said it can produce 10 million doses by the end of the year, AP reported. The company has not announced prices. Pfizer and Roche are studying similar drugs that could report results in the coming weeks.
