drug maker Merco said on friday That its pill to treat COVID-19 was shown in a major clinical trial to cut the risk of hospitalization or death in high-risk people early in their infection in half.
Strong results suggest that a new wave of effective and easy-to-use treatments for COVID will gradually become available in the United States, although supplies are likely to be limited at first. Merck said it would seek emergency authorization from the Food and Drug Administration for its drug, Known as molanupiravir, as soon as possible. The pills could be available by the end of this year.
Merck’s drug will be the first pill treat covid-19; This is likely to be followed by several other antiviral pills that other companies are rushing to bring to market. They have the potential to reach more people than the antibody therapies being widely used in the United States for high-risk patients.
“I think this will translate into thousands of lives being saved around the world, where monoclonal antibodies have little access, and in this country as well,” said Dr. Robert Schafer, an infectious disease specialist at Stanford University.
White House officials on Friday lauded the strong trial data, but they noted that antiviral pills were no substitute for vaccinating more Americans. Despite a growing number of governments and companies mandating vaccines, only 56 percent Americans have been fully vaccinated.
“The right way to think about this is that this is a potentially additional tool in our toolbox to protect people from the worst consequences of COVID,” said White House coronavirus adviser Jeff Gents.
Vaccination is “far and away our best means against Covid-19,” he said. “It can prevent you from getting COVID in the first place, and we want to prevent infections – not just treat them when they happen.”
Results of two other clinical trials antiviral pills, one developed by Pfizer and the other from Atia Pharmaceuticals and Roche, is expected in the next few months.
The Merc drug – named for Mjolnir, the hammer wielded by the thunder god Thor in Norse mythology – is designed to stop the coronavirus from replication by inserting errors into its genetic code. The doctor will prescribe the treatment to patients who will receive pills from pharmacies. The drug is to be taken as four capsules twice a day for five days – a total of 40 tablets during the course of treatment.
The federal government has placed advance orders for 1.7 million courses of treatment at a cost of about $700 per patient. This is about a third of the current cost of a monoclonal antibody treatment, which is usually given to patients via an intravenous hookup.
The dose that the US government has ordered means that only a small proportion of those who become ill with COVID are able to receive treatment, at least initially. Merck said Friday it expects to be able to make enough pills for 10 million people by the end of this year, though it’s not clear how many of those doses will go to the United States or other countries.
is covid Killed about 700,000 Americans. About half of those deaths occurred this year, even as vaccines became widely available.
Merck said an independent board of experts overseeing its clinical trials has recommended that the trial be stopped early because the drug’s benefit to patients has proven to be so reassuring. The company said the FDA agreed with that decision.
Monitor looked at the data in early August, when the study enrolled 775 volunteers in the United States and abroad. Seven percent were hospitalized in the group that received the drug, and none died, compared with a 14 percent rate of hospitalization and mortality in the group that received the placebo pills. Mild side effects, which may include headache, were reported at similar rates in both groups.
The Merck pill appears to be less effective than monoclonal antibody therapies, including: has been in high demand recently. Studies have shown that they reduce hospitalization and death by at least 70 percent in high-risk COVID patients. But antibody treatments are expensive, usually given intravenously and cumbersome for hospitals and clinics to administer.
Angela Rasmussen, a virologist and research scientist at the Vaccines and Infectious Diseases Organization at the University of Saskatchewan, said antiviral pills could have a greater impact as they reach more people.
If the pills cut hospitalizations and deaths by half, “it’s going to translate to potentially saving a huge number of lives with this drug,” she said. “Maybe it’s not doing the same number of monoclonal antibodies, but it’s still going to be huge.”
Merck is the world’s second largest vaccine manufacturer, and it was initially expected to play an important role in fighting the pandemic. But his efforts to make an effective vaccine failed.
With the antiviral pill, Merck “hopes to take the potentially life-threatening situation with COVID and make it manageable,” Merck Chief Executive Robert Davis said in an interview.
Many Wall Street analysts estimate the drug will generate $10 billion in revenue annually, which would quickly put it in the top 10 best-selling drugs every year and provide a huge financial boost for Merck. The company’s stock gained more than 8 percent on Friday.
Merck, which is developing the pill with Ridgeback Biotherapeutics of Miami, has not said which patients it plans to ask the FDA to authorize the drug.
There may be only a limited group of initial recipient patients who are eligible to receive monoclonal antibody treatment: older people and people with medical conditions such as heart disease that put them at higher risk for worse outcomes from COVID. But experts said they hope the drug could eventually be used more widely among many people who test positive for the virus.
In addition to treating people who are already sick with COVID, Merck and other antiviral pill developers are testing whether the pills can prevent illness in people living in the same household who are infected with the virus.
If authorized, Merck’s drug would be the second antiviral treatment for COVID. The first, remdesivir, must be infused and favoritism has been lost among physicians following studies showing that it offers only modest benefits for COVID patients.
Volunteers in Merck’s clinical trial were not to be vaccinated, had to happen Those at high risk of worsening outcomes from covid and had started having symptoms of covid within the last five days.
The company did not disclose whether the drug was more or less effective depending on how quickly the treatment was given.
“If you look at the difference for patients who have been treated on day 2, versus patients who get treated on day 5,” said Dr Celine Gounder, an infectious disease specialist at Bellevue Hospital Center. “What this means is that there are limits in terms of effectiveness because you would need to be able to diagnose on time and get people treated quickly enough.”
Experts also cautioned that the United States did not yet have enough coronavirus testing or enough infrastructure to distribute the pills to take full advantage.
Dr. Gounder and other experts said more antigen testing would be needed for people to get the pills to their advantage quickly, which is conducted here House Or to the drive-thru and returns the result in 15 minutes. But tests are hard to come by and quickly sell out when retailers bring them in stock. (In contrast, it can take several days for laboratories to come up with a positive result in a PCR test.)
Elizabeth Duke, an infectious disease specialist who runs Merck’s study site at the Fred Hutchinson Cancer Research Center in Seattle, said the goal should be for people to show symptoms and start taking the pills within 24 hours of testing positive. He said it would be difficult in the absence of more use of things like telemedicine.
“We need a way where people get positive results and immediately someone can talk to them, review any contraindications to getting the drug. And mail it to their home via FedEx,” she said.
Dr. Duke noted that the influenza pill oseltamivir, known as Tamiflu and the closest equivalent to mollupiravir on the market today, has been under-utilized because it must be given within 48 hours of the onset of symptoms.
“It’s very rarely that oseltamivir is delivered quickly enough to actually help people,” she said. “I would hate to see this happen for molnupiravir and covid.”
Merck’s pill is badly needed in poorer parts of the world, where vaccination rates are low and antibody treatments are mostly unavailable. But this would require a widely available, cheap and easy way to detect the virus, which does not yet exist.
Merck has entered into licenses with eight manufacturers of generic drugs in India, including major players such as Sun Pharma and Dr Reddy’s Laboratories, to manufacture its pill for poor countries. Merck executive Janelle Krishnamurthy, who works on global policy, said they aim to supply to more than 100 low- and middle-income countries. Companies can set prices and negotiate supply deals.
Sheryl Gay Stolberg Contributed reporting.