Merck & Co. / AP
WASHINGTON – Merck & Co. said Friday that its experimental COVID-19 pill has cut hospital admissions and deaths in half in people recently infected with the coronavirus and that it will soon be asking health officials in the US and around the world to to authorize their use.
If released, Merck’s drug would be the first pill to treat COVID-19, a potentially big step forward in fighting the pandemic. All COVID-19 therapies now approved in the US require an IV or injection.
Merck and its partner Ridgeback Biotherapeutics said initial results showed that patients who received the drug called molnupiravir within five days of symptoms of COVID-19 were hospitalized and died about half as often as patients who received a dummy pill. The study tracked 775 adults with mild to moderate COVID-19 who were classified as at higher risk of developing serious illness because of health problems such as obesity, diabetes, or heart disease.
Of the patients taking molnupiravir, 7.3% were either hospitalized or died after 30 days, compared with 14.1% of those taking the dummy pill. After this period, there were no deaths in the drug group 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 The results have been published by the company and have not been peer reviewed.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 plans to introduce them at a future medical meeting.
An independent group of medical experts who monitored the study recommended ending it early because the interim results were so strong. Company executives said they are in discussions with the Food and Drug Administration and plan to submit the data for review in the coming days.
“It exceeded what I thought the drug might be capable of in this clinical trial,” said Dr. Dean Li, Vice President of Merck Research. “If you see a 50% reduction in hospital stays or deaths, it’s a significant clinical impact.”
Side effects were reported by both groups in the Merck study, but were slightly more common in the group that received a dummy pill. The company did not name the problems.
Previous study results showed the drug was of no benefit to patients who were already hospitalized with a serious illness.
The U.S. has approved an antiviral drug, remdesivir, specifically for COVID-19, allowing the emergency use of three antibody therapies that help the immune system fight the virus. But all drugs must be given intravenously or by injection in hospitals or clinics, and supplies have been stretched with the recent surge in the Delta variant.
Health professionals, including leading U.S. infectious disease expert Dr. Anthony Fauci, have long been calling for a convenient pill patients can take when COVID-19 symptoms first appear, much like the decades-old flu drug Tamiflu helps fight influenza. Such drugs are seen as key to controlling future waves of infection and reducing the effects of the pandemic.
Merck’s pill works by disrupting 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 is committed to buying 1.7 million doses of the drug if it is approved by the FDA. Merck has announced that it will produce 10 million cans by the end of the year and has contracts with governments around the world. The company has not disclosed prices.
Several other companies, including Pfizer and Roche, are investigating similar drugs that could release results in the coming weeks and months.
Merck had planned to enroll more than 1,500 patients in its late-stage study before the independent board of directors stopped it prematurely. The results reported on Friday included patients from Latin America, Europe and Africa. Executives estimated that approximately 10% of the patients studied were from the United States
The Associated Press Health and Science Department is supported by the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.