Merck asks FDA for emergency approval of its new antiviral pill for COVID

Merck asks FDA for emergency approval of its new antiviral pill for COVID

Robin Foster, HealthDay Reporter

FRIDAY, Oct. 1, 2021 (HealthDay News) — Pharmaceutical giant Merck & Co. said Friday it will seek federal approval for emergency use of its new antiviral pill molnupiravir, after a clinical trial found the drug reduced the risk of hospitalization or death when administered to high-risk people shortly after infection with COVID-19.

The new drug is just one of many antiviral pills now being tested in trials, and experts say these drugs could give doctors a powerful new weapon to fight the virus.

“More tools and treatments are urgently needed to combat the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families and societies and put pressure on healthcare systems around the world,” CEO and President of Merck Robert Davis said in a company statement. “With these compelling results, we are optimistic that molnupiravir could become an important drug as part of the global effort to fight the pandemic.”

And, he added, “We will continue to work with regulatory authorities on our applications and make every effort to get molnupiravir to patients as quickly as possible.”

Daria Hazuda, vice president of infectious diseases and vaccine discovery at Merck, told the… Washington Post“We have always believed that antivirals, especially oral antivirals, would be a major contributor to the pandemic. Keeping people out of the hospital is incredibly important given the emergence of variants and the ongoing evolution of the virus.”

Infectious disease experts embraced the news.

“I think this will translate into many thousands of lives being saved worldwide, where there is less access to monoclonal antibodies, and also in this country,” said Dr. Robert Shafer, an infectious disease specialist and antiviral therapy expert at Stanford University, The New York Times.

Angela Rasmussen, a virologist and research scientist with the Vaccine and Infectious Disease Organization at the University of Saskatchewan in Canada, agreed that antiviral pills can reach more people than cumbersome antibody treatments.

“If that holds up on the population scale, that will translate into an objectively greater number of lives potentially saved with this drug,” she told the newspaper. Time. “Maybe it won’t do the same [efficacy] numbers as the monoclonal antibodies, but it will still be huge.”

Other antiviral pills in the works

Results of the late-stage study of two other antiviral pills, one developed by Pfizer and the other by Atea Pharmaceuticals and Roche, are expected within the next few months. Time reported.

In the Merck study, which has not been peer-reviewed or published, molnupiravir was taken twice a day for five days.

Merck said an independent board of experts monitoring the study data recommended stopping the trial early because the drug’s benefits to patients were so compelling. The company added that the US Food and Drug Administration had approved that decision.

By early August, the study had enrolled 775 volunteers in the United States and abroad. They had to take the pills within five days of infection. For volunteers who received the drug, their risk of being hospitalized or dying was reduced by 50%, with no significant side effects, compared to those given placebo pills, Merck said.

Only 7% of the volunteers in the group that received the antiviral pills were hospitalized and none of those patients died, compared with 14% hospitalization and eight deaths in the placebo group.

Laboratory and animal studies suggest that the pill may also work against the Delta variant, the After reported. Unlike vaccines or antibodies that target specific proteins on the surface of the virus, molnupiravir introduces nonsensical mutations that scramble the coronavirus’ genetic code so it can’t replicate. That means it could even work on other coronaviruses or RNA viruses.

Merck’s pill can fight other coronaviruses

“As a virologist, that’s one of the things I find particularly exciting,” Hazuda told the After. “Now we have demonstrated the potential to have a drug that could work across multiple coronaviruses. I don’t think this is the last pandemic in our lives, and it would be great to have something readily available that is active. “

The effectiveness of the Merck Pill was lower than monoclonal antibody treatments, which mimic antibodies that the immune system generates naturally when needed. Time reported.

These drugs have been in high demand lately, but they are expensive and time-consuming to administer because they are administered intravenously. But studies have shown that they reduce hospitalizations and deaths by 70% to 85% in high-risk patients, the Time reported.

The federal government has already placed pre-orders for 1.7 million courses of Merck’s antiviral pill, at a price of about $700 per patient, which is one-third of the current cost of monoclonal antibody treatment. Time reported.

Merck — who is developing the pill with Ridgeback Biotherapeutics of Miami — didn’t say which patients it would ask the FDA to approve the treatment.

Initially, that group may be limited to patients eligible for monoclonal antibody treatments, potentially the elderly, and those with medical conditions that put them at high risk for poor outcomes from COVID-19 infection. But experts noted that they expected the drug could eventually be used in many people who test positive for the virus, the Time reported.

If authorized, Merck’s drug would be the second antiviral treatment against COVID-19. The first, remdesivir, has to be infused and has lost favor with doctors as studies have suggested it offers only a modest benefit, the Time reported.

More information

To learn more about COVID antivirals, visit the U.S. Centers for Disease Control and Prevention.


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