Photo: ARNE DEDERT / AFP / Getty Images
The Pharmaceutical company Merck said Friday that its experimental COVID-19 pill cut hospitalizations and deaths in infected people in half. recently with the coronavirus and that it will soon ask health officials in the US and around the world to authorize its use.
If approved, the drug called molnupiravir would be the first effective pill to treat COVID-19, a potentially important advance in efforts to combat the pandemic.
All COVID-19 therapies so far licensed in the US require an IV or injection.
Merck and its partner Ridgeback Biotherapeutics said the first results showed that patients who received the drug molnupiravir, within five days of COVID-19 symptoms they had about half the rate of hospitalization and death than patients who received a dummy pill.
The study tracked 775 adults with mild to moderate COVID-19 who were considered to be at increased risk of serious illness due to health problems such as obesity, diabetes, or 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.
There were no deaths in the drug group after that time period compared to eight deaths in the placebo group, according to Merck.
The results were published by the company and have not been reviewed by external 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 monitoring the trial noted that the interim results were very robust.
When the first results of a study clearly show that a treatment works, no further testing is necessary before requesting authorization.
Company executives said they plan to submit the data for review by the Food and Drug Administration (FDA) in the next few days.
Once the filing is complete, the FDA could make a decision in a few weeks and, if approved, the drug could be on the market soon after.
“It exceeded 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 has a substantial clinical impact.”
Both groups reported side effects in the Merck trial, but they were slightly more common among the group that received a dummy pill. The company did not specify the problems.
Patients take the pill twice a day for five days to complete a course of treatment.
The results of the previous study showed that the drug did not benefit patients who were already hospitalized for a serious illness.
The United States approved an antiviral drug, remdesivir, specifically for COVID-19, and allowed 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 medical clinics, and supplies have been overstated by the latest surge in the delta variant.
Merck’s pill works by interfering with the coronavirus’ ability to copy its genetic code and reproduce. It has shown similar activity against other viruses.
The US government has pledged to purchase 1.7 million doses of the drug if cleared by the FDA.
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 prices.
* Scientists say pill to treat COVID-19 would be months away
* Moderna and Novavax are already working on a vaccine that combines COVID-19 and influenza in a single injection
* One in every 500 US residents has died from COVID-19