Merck, a drugmaker, announced Friday that its experimental pill for COVID-19 patients had reduced hospitalizations by half. This is a significant step forward in the global battle against the pandemic.
It would be the first drug to treat COVID-19 if approved by regulators. This would add a new and easy-to-use weapon in an arsenal already containing the vaccine.
According to the company, it will soon request authorization from health officials around the globe and in the U.S. for the use of the pill. The U.S. Food and Drug Administration could make a decision within weeks. If approved, the drug could be distributed soon.
All and COVID-19 treatment now approved in the U.S. need an IV or injection. A pill that can be taken at home would reduce hospital pressure and help to curb the spread of COVID-19 infections in areas where there is less access.
“This would allow me to treat many more people much faster and, we trust, much cheaper,” Dr. William Schaffner of Vanderbilt University, who wasn’t involved in the research, said.
Merck and Ridgeback Biotherapeutics, Merck’s partner, said that early results showed that patients who received molnupiravir within five days of COVID-19 symptoms experienced about half the death and hospitalization rates than those who received a placebo pill.
The study followed 775 adults with moderate-to-moderate COVID-19. They were high-risk for serious disease due to health conditions such as heart disease, obesity, and diabetes. The results were not reviewed by outside experts as is the norm for reviewing new medical research.
7.3% of patients who received molnupiravir died or were hospitalized after 30 days. This compares with 14.1% for those who took the dummy pills. According to Merck, after that time, no deaths occurred among patients who received the drug. Eight were in the placebo group.
The trial was so successful that an independent panel of medical experts recommended it be stopped immediately.
Executives from the company stated that they will submit the data to FDA within the next few days.
Experts stressed the importance vaccines in controlling the pandemic.
Jeff Zients, White House coronavirus coordinator, stated that vaccination will continue to be the main strategy of the government for controlling the pandemic. He stated, “We want to prevent infection and not wait to treat them when it happens.”
The government’s most respected authority on infectious diseases, Dr. Anthony Fauci, called Merck’s results “very good news.”
Merck did not test the drug on people who had been vaccinated. FDA regulators might authorize it for wider use in patients with breakthrough COVID-19 symptoms.
Andrew Pekosz, Johns Hopkins University, predicted that vaccines and antiviral medications would eventually be combined to combat the worst effects COVID-19.
Pekosz, a specialist in virology, stated that these should not be considered as a replacement for vaccination. They can be combined to reduce severe diseases.
For five days, patients take four tablets of molnupiravir twice daily for five days. Both groups reported side effects in the Merck trial. However, they were slightly more common for those who took a placebo pill. The problem was not specified by the company.
An earlier study found that the drug didn’t benefit patients already in hospital with severe illness. This is not surprising considering that antiviral medications are most effective when they are administered before the virus becomes more severe.
The United States has approved remdesivir for COVID-19 and allows emergency use of three antiviral drugs that aid the immune system to fight the virus. All the drugs must be administered intravenously or by injection in hospitals and clinics. The latest strain of the delta virus has made it more expensive.
High-risk patients have seen antibody drugs reduce hospitalizations and deaths by 70%. This is roughly 20 percentage points less than Merck’s pill. Experts cautioned against comparing the results of the two due to the preliminary nature Merck’s data.
Experts in health, including Fauci have long advocated for a pill patients could take to relieve COVID-19 symptoms when they first occur. This would be similar to Tamiflu, which is used to speed up recovery from flu symptoms.
Merck’s pill, like other antivirals works by interfering in the virus’s ability copy its genetic code or reproduce itself.
If the FDA approves the drug, the U.S. government will purchase enough pills to treat 1.7million people. Merck claimed it could produce 10 million pills by the end of this year, and has agreements with governments around the world. Prices have not been announced by the company.
Roche and Pfizer are also studying similar drugs. They could report their findings in the coming weeks or months.
Merck had originally planned to enroll over 1,500 patients in its final-stage trial, but the independent board stopped it before it could be completed. The Friday results included patients from Latin America, Europe, and Africa. According to executives, 10% of the patients were American.