Drugmaker Merck has said its experimental COVID-19 pill reduced hospitalisations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the United States and around the world to authorise its use.
If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major step forward in global efforts to control the pandemic. All COVID-19 therapies now authorised in the US require an IV or injection.
“With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic,” said Robert Davis, the company’s CEO and president, in a statement on Friday.
A pill that could be taken at home, by contrast, could keep many patients out of the hospital, easing the workload on strained healthcare professionals.
It could also help curb outbreaks in lower-income countries that do not have access to the more expensive infusion therapies.
Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalisation and death as patients who received a dummy pill.
The study tracked 775 adults with mild-to-moderate COVID-19 who were considered at higher risk for severe disease due to health problems such as obesity, diabetes or heart disease. The results have not been peer-reviewed by outside experts, the usual procedure for vetting new medical research.
Among patients taking molnupiravir, 7.3 percent were either hospitalised or died at the end of 30 days, compared with 14.1 percent of those getting the dummy pill.
There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck.
An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong.
That is typical when early results show so clearly that a treatment works that there is no need for further testing before applying for authorisation. 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 within weeks — and, if approved, the drug could be on the market soon after. Merck studied its drug only in people who were not vaccinated.
But FDA regulators may consider authorising it for broader use in vaccinated patients who get COVID-19 symptoms.
“It exceeded 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 percent reduction in hospitalisation or death that’s a substantial clinical impact.”
Peter Horby, a professor of emerging infectious diseases at the University of Oxford, called the interim results “very encouraging”.
“A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID,” he said.
Oksana Pyzik, a global health adviser and lecturer at University College London, told Al Jazeera that the Merck pill was “much more convenient than many of the other types of treatments including monoclonal antibodies which were much more expensive and more complicated”.
“So it’s about time that we were able to introduce an easy to take a tablet at home within our tool kit of various medications that can help prevent and fight the coronavirus,” she added.
However, experts have also cautioned they would like to see the complete underlying data, and stressed that if eventually approved, the drug should complement highly effective vaccines, rather than be taken instead of them.
Patients take eight pills per day for five days. Side effects were reported by both groups 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.
Earlier study results showed the drug did not benefit patients who were already hospitalised with severe disease.
The US has approved one antiviral drug, remdesivir, specifically for COVID-19, and allowed emergency use of three antibody therapies that help the immune system fight the virus.
But all the drugs have to be given by IV or injection at hospitals or medical clinics, and supplies have been stretched by the latest surge of the Delta variant.
Health experts including the top US infectious disease expert Anthony Fauci have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way the standard flu medication Tamiflu helps fight influenza.