American drugmaker company Merck has claimed that its experimental COVID-19 pill Molnupiravir efficiently reduced hospitalizations and death rates by half in recently infected patients. Merck said that the company would soon request the health officials of the United States and the World to authorize its consumption.
In a statement on Friday, the company’s CEO and president Robert Davis said, “With these compelling results, we are optimistic that Molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”
If the request is accepted, the drug would be proved to be the first pill to treat COVID-19 and it would be a major step forward to control the pandemic as all other authorized therapies in the US require an injection or IV.
A pill that could be taken at home and could keep many patients out of the hospital, easing the overloaded healthcare system.
It could also help to stop the outbreaks in third-world countries that do not have access to the more expensive infusion therapies.
Merck and its partner Ridgeback Biotherapeutics said that early results showed 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 received a dummy pill.
A study was conducted in which they tracked 775 adults with mild to moderate COVID-19 who were considered at higher risk for severe disease due to health problems like obesity, diabetes, or heart disease. The results have not been reviewed by outside experts, the usual procedure for vetting new medical research.
Among patients taking Molnupiravir pills, 7.3 per cent were either hospitalized or died at the end of 30 days, compared with 14.1 per cent of those not taking the pill, instead, taking a dummy pill.
There were no deaths in the drugged 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 authorization. Company executives said they plan to submit the data for review by the Food and Drug Administration in the coming days.
Once they submit the data, the FDA would make a decision within weeks and if approved, the drug could be on the market soon after. Merck tested the pills only in people who were not vaccinated. Therefore, FDA regulators might consider authorizing it for broader use in vaccinated patients who get COVID-19 symptoms.
The Vice President of Merck Research Laboratories Dr Dean Li said, “It exceeded what I thought the drug might be able to do in this clinical trial.”
Li added, “When you see a 50 per cent reduction in hospitalization or death that’s a substantial clinical impact.”
A Professor of emerging infectious diseases at the University of Oxford Peter Horby called the interim results very encouraging. He said, “A safe, affordable, and effective oral antiviral would be a huge advance in the fight against COVID.”
In an interview, a global health adviser and lecturer at University College London said that the Merck pill was much more efficient and convenient than many of the other types of therapies including monoclonal antibodies which were more expensive and complicated.
She added, “So it’s about time that we were able to introduce an easy-to-take tablet at home within our tool kit of various medications that can help prevent and fight the coronavirus.”
However, experts have also shown concerns that 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.
The reports have also pointed out that the patients take eight pills per day for five days and toxic 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 that the drug did not benefit patients who were already hospitalized 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.
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.
