WASHINGTON (AP) – Merck & Co. said on Friday that its experimental COVID-19 pill was halving hospitalizations and deaths among people recently infected with the coronavirus and that it would soon ask health officials in the United States and in the world to authorize its use.
If approved, Merck’s drug would be the first pill to treat COVID-19, a potentially major breakthrough in efforts to fight the pandemic. All COVID-19 therapies now authorized in the United States require an intravenous or injection.
Merck and its partner Ridgeback Biotherapeutics said initial results showed that 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 have received a dummy pill. The study followed 775 adults with mild to moderate COVID-19 who were considered to be at higher risk of serious illness due to health conditions such as obesity, diabetes or heart disease.
Of the patients on molnupiravir, 7.3% were hospitalized or died after 30 days, compared with 14.1% of those on the dummy pill. There were no deaths in the drug group after this period, compared to eight deaths in the placebo group, according to Merck. The results have been published by the company and have not been peer reviewed. Merck said he plans to present them at a future medical meeting.
An independent group of medical experts overseeing the trial recommended stopping it early because the intermediate results were so strong. Company executives said they are in talks with the Food and Drug Administration and plan to submit the data for review in the coming days.
“It went beyond what I thought the drug might be able to do in this clinical trial,” said Dr. Dean Li, vice president of research at Merck. “When you see a 50% reduction in hospitalizations or deaths, it has a substantial clinical impact. “
Side effects were reported by both groups in the Merck trial, but were slightly more common in the dummy pill group. The company did not specify the problems.
Results from previous studies showed that the drug did not benefit patients who were already hospitalized with serious illness.
The United States has approved an antiviral drug, remdesivir, specifically for COVID-19, and has authorized the emergency use of three antibody therapies that help the immune system fight the virus. But all drugs have to be given intravenously or by injection in hospitals or medical clinics, and stocks have been depleted by the latest wave of the delta variant.
Health experts including America’s top infectious disease expert Dr.Anthony Fauci have long called for a convenient pill that patients could take when symptoms of COVID-19 first appear, much like the flu drug Decades old Tamiflu helps fight the flu. These drugs are considered essential for controlling future waves of infection and reducing the impact of the pandemic.
The Merck pill works by interfering with an enzyme that the coronavirus uses to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.
The US government has pledged to purchase 1.7 million doses of the drug if it is cleared by the FDA. Merck said it could produce 10 million doses by the end of the year and had contracts with governments around the world. The company has not announced a price.
Several other companies, including Pfizer and Roche, are studying similar drugs that may yield results in the weeks and months to come.
Merck had planned to enroll more than 1,500 patients in its advanced stage trial before independent board terminated it prematurely. The results reported on Friday included patients enrolled in Latin America, Europe and Africa. Executives estimated that about 10% of the patients studied were from the United States
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