WASHINGTON >> Drugmaker Merck & Co. said today its experimental COVID-19 pill is halving hospitalizations and deaths among people recently infected with the coronavirus and that it would soon ask state health officials United and the whole world to authorize its use.
If approved, the drug would be the first pill to treat COVID-19, a potentially major breakthrough in global efforts to control the pandemic. All COVID-19 therapies now authorized in the United States require an intravenous or injection.
A pill that could be taken at home, on the other hand, could prevent many patients from going to the hospital, easing the workload of healthcare professionals under pressure. It could also help curb epidemics in low-income countries that lack access to the more expensive infusion therapies.
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. The results were not reviewed by external experts, the usual procedure for validating new medical research.
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 with eight deaths in the placebo group, according to Merck.
An independent group of medical experts overseeing the trial recommended stopping it early because the intermediate results were so strong. This is typical when the first results show so clearly that a treatment is working that there is no need for further testing before seeking authorization. Company executives said they plan to submit the data for review by the Food and Drug Administration in the coming days.
Once the submission is complete, the FDA could make a decision in a matter of weeks – and, if approved, the drug could be on the market soon after. Merck has only studied its drug in unvaccinated people. But FDA regulators may consider clearing it for wider use in vaccinated patients who show symptoms of COVID-19.
“It went beyond what I thought the drug might be able to do in this clinical trial,” said Dr. Dean Li, vice president of Merck Research Laboratories. “When you see a 50% reduction in hospitalizations or deaths, it has a substantial clinical impact. “
Patients take the pill twice a day for five days. 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 leading infectious disease expert Dr.Anthony Fauci have long called for a convenient pill that patients could take when symptoms of COVID-19 first appear, similar to how the standard influenza drug Tamiflu helps fight the flu.
These drugs are considered essential for 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 drugs are essential as billions of people around the world remain unvaccinated.
The Merck pill works by interfering with the ability of the coronavirus to copy its genetic code and to 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 could 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. Results reported today included patients recruited from Latin America, Europe and Africa. Executives estimated that about 10% of the patients studied were from the United States