Drugmaker Merck said on Friday it would apply for approval for its first antiviral pill for COVID-19 after its drug, known as molupiravir, was shown in clinical trials to help people at high risk be hospitalized. The risk of admission or death can be reduced by half. early in their transition.
The treatments could be the first in a wave of antiviral pills that experts say could be a powerful new tool in the pandemic effort as they continue to be used widely in the United States. Antibodies can reach more people than they can treat. Similar patients.
“I think thousands of lives will be saved around the world where monoclonal antibodies are scarce and in this country,” said Dr. Robert Schaefer, infectious disease specialist and antiviral therapist at Stanford University.
Final-stage study results of two other antiviral pills, one from Pfizer and the other from Aetia Pharmaceuticals and Roche, are expected in the next few months.
Merck, which is designed to prevent the coronavirus from recurring, must be taken four capsules twice daily for five days.
Merck said an independent panel of experts monitoring trial data had recommended stopping trials early because the benefits of the drug were so convincing to patients. The company said the Food and Drug Administration approved the decision.
For the study, the Monitor looked at data in early August when the study enrolled 775 volunteers in the US and abroad. Volunteers who received the drug had a 50 percent reduced risk of hospitalization or death compared with those who received a placebo pill with no side effects, according to a press release announcing the results.
Seven percent of the volunteers in the group were hospitalized and none died, compared with 14 percent of hospitalizations and deaths — including eight deaths — in the placebo group.
Merck pills are less effective than treatment with monoclonal antibodies, which mimic antibodies that the immune system naturally produces to fight viruses. Recently, these drugs are in great demand but are expensive, are usually given intravenously, and are complex and time-consuming to administer in hospitals and clinics. Studies show that they reduce hospital stays and deaths in high-risk patients with COVID by 70 to 85 percent.
However, Angela Rasmussen, a virologist and researcher at the University of Saskatchewan’s Organization of Vaccines and Infectious Diseases, said that antiviral pills could have a greater effect when reaching more people.
‘If kept at a population level,’ he said, ‘there would be a large number of lives that could be saved with this drug,’ adding, ‘it is impossible to reach the number of monoclonal drugs. Antibodies, but they will still be large. ”
The federal government has ordered 1.7 million drug programs from Merck at a cost of about $700 per patient. This corresponds to about a third of the current cost of treatment with monoclonal antibodies.
Merck, which developed the pill with Ridgeback Biotherapeutics from its Miami partner, has not said which patients it intends to refer to the FDA.
It may be approved initially for a limited group of patients eligible for treatment with monoclonal antibodies: potentially the elderly and those with medical conditions that put them at higher risk for poorer COVID outcomes. However, experts hope the drug will eventually become more widespread in the many people who test positive for the virus.
If allowed, Merck will become the second antiviral treatment for COVID. The first, remdezivir, was intended for use and was not favored by doctors because studies showed it only benefited patients with COVID.