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


WebMD Health

Robin Foster, HealthDay reporter

FRIDAY, October 1, 2021 (HealthDay News) – Pharmaceutical giant Merck & Co. said Friday it will apply for state approval for the emergency use of its new antiviral pill, molnupiravir, after a clinical study showed the drug’s risk hospital stay halved or death when administered to high-risk patients shortly after infection with COVID-19.

The new drug is just one of several antiviral pills currently being tested in studies, and experts say these drugs could offer doctors a powerful new weapon to fight the virus.

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

He added, “We will continue to work with the regulatory authorities on our applications and do everything we can to get molnupiravir to patients as soon as possible.”

Daria Hazuda, vice president of infectious diseases and vaccine development at Merck, told the Washington Post, “We have always believed that antivirals, especially oral antivirals, would make an important contribution to the pandemic. It is incredibly important to keep people out of the hospital for the emergence of variants and further development of the virus. “

Infectious disease experts picked up the news.

“I think it will save many thousands of lives around the world where there is less access to monoclonal antibodies, and in this country too,” said Dr. Robert Shafer, an infectious disease specialist and expert in antiviral therapy at Stanford University The New York Times.

Angela Rasmussen, a virologist and researcher 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 at the population level, it will result in an objectively greater number of lives that may be saved with this drug,” she told the Times. “Maybe it doesn’t do the same [efficacy] Numbers like the monoclonal antibodies, but it’s still going to be huge. “

Other antiviral pills in the works

Late-stage study results of two other antiviral pills, one from Pfizer and the other from Atea Pharmaceuticals and Roche, are expected in the next few months, the Times reported.

In the Merck study, which was never peer-reviewed or published, molnupiravir was taken twice daily for five days.

Merck said an independent panel of experts that monitored its study data recommended stopping the study early because the drug’s benefit to patients was so compelling. The company added that the U.S. Food and Drug Administration approved the decision.

As of early August, 775 volunteers in the US and abroad were involved in the study. They had to take the pills within five days of the infection. For volunteers given the drug, the risk of hospitalization or death decreased by 50% without fear of any side effects, compared to those given placebo pills, Merck said.

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

Laboratory and animal tests suggest that the pill could also work against the Delta variant, the Post reported. Unlike vaccines or antibodies that target specific proteins on the surface of the virus, molnupiravir introduces nonsense mutations that disrupt the coronavirus’ genetic code so it cannot replicate. That said, it could even work for other coronaviruses or RNA viruses.

The Merck pill can fight other coronaviruses

“As a virologist, I find that particularly exciting,” Hazuda told the post. “Now we’ve proven the potential for a drug that could work against multiple coronaviruses. I don’t think this will be the last pandemic in our lives and it would be amazing to have something available that is active. “

The Merck pill was less effective than monoclonal antibody treatments, which mimick antibodies that the immune system naturally makes when needed, the Times reported.

These drugs have recently been in high demand, but they are expensive and time-consuming to administer because they are administered intravenously. However, studies have shown that they reduce hospital stays and deaths in high-risk patients by 70 to 85%, the Times reported.

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

Merck – which is developing the pill with Miami-based Ridgeback Biotherapeutics – didn’t say which patients the FDA would approve for treatment.

Initially, this group may be limited to patients eligible for monoclonal antibody treatment, potentially the elderly and those with conditions that put them at high risk for poor outcomes from COVID-19 infection. However, experts noted that they expected the drug could eventually be used on many people who tested positive for the virus, the Times reported.

If approved, Merck’s drug would be the second antiviral treatment for COVID-19. The first, remdesivir, has to be infused and has declined in popularity among doctors as studies have shown it offers only modest benefits, the Times reported.

More information

Visit the U.S. Centers for Disease Control and Prevention to learn about COVID antiviral drugs.

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