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

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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 trials, 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 health systems around the world,” said Merck CEO and President Robert Davis said in a company opinion. “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, said 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 given the emergence of variants and the 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, infectious disease specialist and antiviral therapy expert 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 persists on the population scale, it will result in an objectively larger number of lives that may be saved with this drug,” she said 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 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, the study had 775 volunteers in the United States and abroad. They had to take the pills within five days of the infection. Volunteers given the drug reduced the risk of hospitalization or death with no side effects by 50% 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 14% hospitalization rate 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 mess up the genetic code of the coronavirus so that 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,” said Hazuda 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 treatment with monoclonal antibodies, which mimic antibodies that the immune system makes naturally when needed Times reported.

These drugs are in great demand recently, 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% Times reported.

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

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

First, this group may be limited to patients eligible for treatment with monoclonal antibodies, 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 that the drug could eventually be used on many people who tested positive for the virus Times reported.

If approved, Merck’s drug would be the second antiviral treatment for COVID-19. The first, remdesivir, requires an infusion and has lost its popularity with doctors as studies have shown that it offers only modest benefits Times reported.

More information

Visit the U.S. Centers for Disease Control and Prevention to learn more Antivirus for COVID.


Thank You For Reading!


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