The pharmaceutical giant Merck indicated that its experimental COVID-19 pill cut hospitalizations and deaths in half in people recently infected with the coronavirus and that it will soon ask the health authorities of the United States and the world to authorize its use.
If licensed, Merck’s drug would be the first pill shown to treat COVID-19, a potentially significant advance in the fight against the pandemic. All currently licensed COVID-19 therapies in the United States require an IV or injection.
Merck and its partner Ridgeback Biotherapeutics said early results showed that patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the hospitalization and death rate as patients. they received a dummy pill. The study followed 775 adults with mild-to-moderate COVID-19 who were considered to be at increased risk for severe illness due to underlying health problems such as obesity, diabetes, and heart disease.
Among the patients taking molnupiravir, 7.3% were hospitalized or died within 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 period, in contrast to eight deaths in the placebo group. The results were released by the company and have not been reviewed by outside experts, the usual procedure for examining new medical research. Merck said it plans to present them at a future medical meeting.
An independent group of medical experts who oversaw the trial recommended stopping it early because the interim results were very strong. This is typical when early effects show so clearly that a treatment works that no further testing is necessary before requesting authorization. Company officials said they plan to submit the data for review by the Food and Drug Administration (FDA) in the coming days.
After filing is complete, the FDA could make a decision in a matter of weeks and, if approved, the drug could hit the market soon after. Merck has studied its medicine only in unvaccinated people. But FDA regulators could consider authorizing it for wider use in inoculated patients with COVID-19 symptoms.
“It surpassed what I thought the drug could do in this clinical trial,” said Dr. Dean Li, vice president of Merck Research Laboratories. “When you see a 50% reduction in hospitalization or death, that’s a substantial clinical impact.”
Patients take eight pills a day for five days. Side effects were reported by both groups in the Merck trial, but were slightly more common among the group that received a dummy pill. The company did not specify the problems.
Results from previous studies showed that the drug did not benefit patients who were already hospitalized with severe COVID-19.
The United States has approved an antiviral drug, remdesivir, specifically for COVID-19, and has allowed the emergency use of three antibody therapies that help the immune system fight the virus. However, all drugs must be administered intravenously or injected in hospitals or medical clinics, and supplies have been depleted with the latest wave of the Delta variant.
Health experts, including America’s leading infectious disease expert, Dr. Anthony Fauci, have long called for a practical pill that patients can take when the first symptoms of COVID-19 appear. , similar to how the old Tamiflu helps fight the flu. These drugs are considered key to controlling future waves of infection and reducing the impact of the pandemic.
Vaccines remain the most effective way to protect against COVID-19, but effective medications are critical as billions of people around the world remain uninoculated.
Merck’s pill works by interfering with an enzyme that the coronavirus uses to copy its genetic code and reproduce. The pill has shown a similar effect on other viruses.
The US government has pledged to buy 1.7 million doses of the drug if the FDA authorizes it. 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 pricing.
Other companies, such as Pfizer and Roche, are studying similar drugs and could present results in the coming weeks and months.