Merck says it has the first effective antiviral pill for Covid
Drugmaker Merck said on Friday it would seek authorization for the first antiviral pill for Covid after its drug, known as molnupiravir, was shown in a clinical trial to halve the risk of hospitalization or death when given to people at high risk at the onset of their infections.
The treatment could become the first in a wave of antiviral pills, which experts say could offer a powerful new tool in efforts to tame the pandemic, as they could reach more people than antibody treatments that are widely used. in the United States for similar patients.
“I think this will translate to several thousand lives saved around the world, where there is less access to monoclonal antibodies, and in this country as well,” said Dr Robert Shafer, specialist in infectious diseases and expert in antiviral therapy at Stanford University.
The results of the late stage study of two additional antiviral pills, one developed by Pfizer and the other by Atea Pharmaceuticals and Roche, are expected in the coming months.
The drug Merck, which is designed to prevent the coronavirus from replicating, should be taken as four capsules twice a day for five days.
Merck said an independent expert panel monitoring the data from its study had recommended that its trial be stopped early because the drug’s benefits to patients had proven to be so compelling. The company said the Food and Drug Administration accepted the decision.
For the research, monitors looked at data up to early August, when the study recruited 775 volunteers in the United States and overseas. For volunteers who received the drug, their risk of being hospitalized or dying was reduced by 50%, with no side effects of concern, compared to those who received placebo pills, Merck said in a press release announcing the results. Merck announced the results in a statement that did not include some detailed data from the trial that experts said would be crucial in determining how the drug will be used.
Seven percent of volunteers in the drug group were hospitalized and none of them died, compared with a 14% hospitalization and death rate, including eight deaths, in the placebo group.
The effectiveness of the Merck pill was lower than that of monoclonal antibody treatments, which mimic the antibodies that the immune system naturally generates when fighting the virus. These drugs have been in high demand recently, but they are expensive, are usually administered intravenously, and have proven to be heavy and labor intensive for hospitals and clinics. Studies have shown that they reduce hospitalizations and deaths by 70-85% in similar high-risk Covid patients.
Still, Angela Rasmussen, a virologist and researcher at the Vaccine and Infectious Disease Organization at the University of Saskatchewan, said antiviral pills could have a bigger impact by reaching more people.
“If it holds at the scale of the population,” she said, “this will translate into an objectively greater number of lives potentially saved by this drug,” adding that “maybe he does not make the same numbers as the monoclonal drug. antibodies, but it’s always going to be huge.
The federal government has placed advance orders for 1.7 million treatments of the drug from Merck, at a price of about $ 700 per patient. This is about a third of the current cost of monoclonal antibody treatment.
Merck – which is developing the pill with its partner, Ridgeback Biotherapeutics of Miami – did not specify for which patients it plans to ask the FDA to clear the drug.
It may be initially cleared for the limited group of patients eligible to receive monoclonal antibody treatments: possibly the elderly and those whose medical conditions put them at high risk of poor Covid outcomes. But experts said they expected the drug could eventually be used more widely, in many people who tested positive for the virus.
If approved, Merck’s drug would be the second antiviral treatment for Covid. The first, remdesivir, needs to be infused and has fallen out of favor with clinicians as studies have suggested that it offers only modest benefit for Covid patients.