If those promising preliminary results hold, the new drug could help fill a significant gap in the world\u2019s Covid-19 arsenal.<\/b>
\nNews that an experimental antiviral drug from Merck appears to halve the risk of hospitalization or death from Covid-19 has bolstered hopes of finding a simple at-home treatment for the virus. The drug, molnupiravir, is given as a pill. It performed well enough in a late-stage clinical trial of adults at high risk of severe Covid-19 that the independent review board overseeing the study recommended that it be ended early. Now Merck and its partner Ridgeback Biotherapeutics will seek FDA authorization for the drug \u201cas soon as possible,\u201d they said Friday. If those promising preliminary results hold, the new drug could help fill a significant gap in the world\u2019s Covid-19 arsenal. As the pandemic nears the end of its second year, there are still only a handful of treatments for Covid-19 \u2014 and none that people can take at home. Finding a drug that can minimize the risk of severe illness could ease the burden on the country\u2019s hospitals and blunt future surges of infection, in combination with vaccines and public health measures like mask-wearing. Currently, \u201cvery few treatment options [are] available,\u201d said Matthew Hall, a biologist at the National Institutes of Health\u2019s National Center for Advancing Translational Sciences. \u201cSomeone can go to an infusion center and be infused with a neutralizing antibody, but [there\u2019s] nothing in a pill form that’s able to just be prescribed to take in early in an infection to reduce the severity of symptoms and the extent of symptoms.\u201d At a press conference Friday, the president\u2019s chief medical adviser, Anthony Fauci, called the trial results \u201cimpressive\u201d and \u201cvery good news.\u201d Fauci said that Merck had briefed government health officials last night on the trial data. While much of the attention early in the pandemic focused on vaccine development, the quest for drugs to treat Covid-19 has gained steam in recent months. The Biden administration has channeled billions of dollars into finding new therapies, seeing them as crucial to help bring the pandemic to an end. Vaccines are powerful at preventing infection but cannot treat the disease. The only Covid antiviral drug available now, Gilead Sciences’ remdesivir, must be given as an infusion in a clinical setting, and evidence for its effectiveness is mixed. And although monoclonal antibodies are more effective than molnupiravir at reducing the risk of hospitalization and death, they are expensive and hard to make and can only be given via infusion or injection. Other available treatments, like the steroid dexamethasone, can reduce the risk of death in severely ill patients, but are not effective in people with mild or moderate Covid. The Merck pill is taken twice a day for five days. The data the company released Friday comes from a global clinical trial in unvaccinated adults. All had at least one condition that increased their risk of developing severe Covid-19 \u2014 such as being older than 60, obese, or having diabetes or heart disease. The preliminary findings are based on data from 775 participants. Merck had initially aimed to enroll 1,550 people in the study. All of the trial participants had tested positive for mild or moderate Covid-19 within five days of joining the study. Just over 7 percent of patients who received the drug had been hospitalized through the 29th day of the study, while 14.1 percent in the placebo group were hospitalized or died, Merck said. No deaths were reported in patients given molnupiravir during that time, but eight people given the placebo died. Side effects were mild. The study ended early at the recommendation of the independent data and safety board overseeing the research, and with the assent of the FDA, Merck said. The company did not say which groups would be covered by its authorization request. The study examined people at high risk of severe illness and death, rather than the broader adult population. Hall said that ideally, molnupiravir would be given to anyone who tests positive for Covid-19 in the first few days after diagnosis. \u201cIt should, irrespective of their vaccination status and things like that, it should reduce the length of symptoms,\u201d he said. Merck expects to produce 10 million treatment courses of molnupiravir by the end of 2021. It has also licensed the drug to five Indian manufacturers to produce doses for India and more than 100 low- and middle-income countries. The company said it will offer tiered pricing based on a nation\u2019s ability to pay. The U.S. government agreed earlier this year to purchase 1.7 million treatment courses of the drug pending FDA authorization, at a cost of $1.2 billion. Jeffrey Zients, the White House Covid-19 coordinator, said Friday that the government has options to purchase additional doses. He also cautioned that any antiviral would not supplant the need to vaccinate as many Americans as possible. \u201cIf approved, this is an additional tool in our toolbox, but it is really important to remember that vaccination remains our best tool.\u201d Merck plans to publish the data from the clinical trial, which has not undergone peer review, in a scientific journal. The company will also seek authorization or approval from regulatory agencies outside the United States. David Lim contributed to this report.<\/p>\n