Merck & Co. said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use.
If cleared, Merck’s drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.
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 hospitalization and death as patients who received a dummy pill. The study tracked 775 adults with mild-to-moderate COVID-19 who were considered higher risk for severe disease because of health problems such as obesity, diabetes or heart disease.
Among patients taking molnupiravir, 7.3 per cent were either hospitalized or died at the end of 30 days, compared with 14.1 per cent 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.
The results were released by the company and have not been peer reviewed. Merck said it plans to present them at a future medical meeting.
Health Canada has been reviewing data around molnupiravir since August as part of its rolling review of potential treatments.
Federal officials told reporters on Friday that there is no specific timeline for completing that review.
“The interest in the Merck antiviral is because of ease of use,” said chief public health officer Dr. Theresa Tam during the briefing. “And you can give it up to five days in the start of someone’s clinical course, so you have a bit of time.”
Company plans to submit data to FDA
An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong. Company executives said they are in discussions with the U.S. Food and Drug Administration (FDA) and plan to submit the data for review in the coming days.
“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. “When you see a 50 per cent reduction in hospitalization or death, that’s a substantial clinical impact.”
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 effects.
Earlier study results showed the drug did not benefit patients who were already hospitalized with severe disease.
The U.S. 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.
‘Very good news,’ says Fauci
Health experts, including the top U.S. infectious disease expert Dr. Anthony Fauci, have long called for a convenient pill that patients could take when COVID-19 symptoms first appear, much the way the decades-old flu medication Tamiflu helps fight influenza. Such medications are seen as key to controlling future waves of infection and reducing the impact of the pandemic.
“The news of the efficacy of this particular anti-viral is obviously very good news,” Fauci said during a Friday briefing. “The company, when they briefed us, had mentioned that they will be submitting their data to the FDA imminently. The data are impressive.”
Merck’s pill works by interfering with an enzyme the coronavirus uses to copy its genetic code and reproduce itself. It has shown similar activity against other viruses.
“This could be a huge step forward,” said Dr. Matthew Oughton, an infectious diseases specialist in Montreal, during an interview with CBC News.
There would be major benefits from the pill if subsequent trials back up the early results, he added, noting the company’s raw data has not yet been released.
