The drugmaker Merck said Friday that it would seek authorization
for the first antiviral pill for COVID-19 after its drug, known as
molnupiravir, was shown in a clinical trial to cut the risk of hospitalization
or death in half when given to high-risk people early in their infections.
اضافة اعلان
The treatment could become the first in a wave of antiviral pill
products, which experts say could offer a powerful new tool in efforts to tame
the pandemic, as they could reach more people than the antibody treatments that
are being widely used in the United States for similar patients.
“I think it will translate into many thousands of lives being
saved worldwide, where there’s less access to monoclonal antibodies, and in
this country, too,” said Dr. Robert Shafer, an infectious disease specialist
and expert on antiviral therapy at Stanford University.
Late-stage study results of two other antiviral pills, one
developed by Pfizer and the other by Atea Pharmaceuticals and Roche, are
expected within the next few months.
The Merck drug, which is designed to stop the coronavirus from
replicating, is to be taken as four capsules twice a day for five days.
Merck said an independent board of experts monitoring its study
data had recommended that its trial be stopped early because the drug’s benefit
to patients had proved so convincing. The company said that the Food and Drug
Administration had agreed with that decision.
For the research, the monitors looked at data through early
August, when the study had enrolled 775 volunteers in the United States and
overseas. For volunteers who received the drug, their risk of being
hospitalized or dying fell 50%, without any concerning side effects, compared
with those who received placebo pills, Merck said in a news release announcing
the findings.
Seven percent of volunteers in the group that received the drug
were hospitalized, and none of them died, compared with a 14 percent rate of
hospitalization and death — including eight deaths — in the group that received
the placebo.
The Merck pill’s efficacy was lower than that of monoclonal
antibody treatments, which mimic antibodies that the immune system generates
naturally when fighting the virus. Those drugs have been in high demand
recently, but they are expensive, are typically given intravenously, and have
proved cumbersome and labor-intensive for hospitals and clinics to administer.
Studies have shown that they reduce hospitalizations and deaths 70 percent to
85 percent in similar high-risk COVID patients.
Still, Angela Rasmussen, a virus expert and research scientist
at the Vaccine and Infectious Disease Organization at the University of
Saskatchewan, said that antiviral pills could have a greater impact by virtue
of reaching more people.
“If that holds up at the population scale,” she said, “that is
going to translate to an objectively larger number of lives saved potentially
with this drug. Maybe it isn’t doing the same numbers as the monoclonal
antibodies, but it’s still going to be huge.”
The federal government has placed advance orders for 1.7 million
courses of Merck’s drug, at a price of about $700 per patient. That is about
one-third of the current cost of a monoclonal antibody treatment.
Merck — which is developing the pill with its partner, Ridgeback
Biotherapeutics of Miami — has not said which patients it plans to ask the FDA
to approve the drug for.
It may be initially approved for the limited group of patients
who are eligible to receive monoclonal antibody treatments: possibly older
people and those with medical conditions that put them at high risk for bad
outcomes from COVID. But experts said they expected that the drug might
eventually be used more widely, in many people who test positive for the virus.
If authorized, Merck’s drug would be the second antiviral
treatment for COVID. The first, remdesivir, must be infused and has lost favor
among clinicians as studies have suggested that it offers only modest benefit
for
COVID patients.
Read More
Health
.jpg)
.jpg)
