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Merck seeks FDA emergency use authorization for antiviral Covid-19 treatment molnupiravir


CNN

By Jamie Gumbrecht and Maggie Fox, CNN

Merck said Monday it is seeking US Food and Drug Administration emergency use authorization for its experimental antiviral Covid-19 treatment, molnupiravir.

If authorization is granted, the drug, made by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral treatment to fight Covid-19. It comes in capsule form.

Merck said it is asking for authorization for the capsules to treat infected adults who are at risk of progressing to severe Covid-19 disease or hospitalization. Its submission is based on a study that was stopped at the interim point because the drug was working so well in more than 700 patients randomly assigned to take either molnupiravir or a placebo.

“At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients,” the company said in a statement.

“Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo.” None of the volunteers in the trial had been vaccinated.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck CEO and President Robert Davis said in the statement.

Data from the trial has not yet been peer-reviewed or published.

“Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022,” the company said.

It has already sold 1.7 million treatment courses to the US government. The company said it will offer tiered pricing to provide access around the world, and will work with generic drug manufacturers to speed availability to low- and middle-income countries.

At a White House Covid-19 briefing last week, Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, called the trial results “very encouraging,” but said the drug needs close scrutiny by the FDA.

“It is very important that this now must go through the usual process of careful examination of the data by the Food and Drug Administration both for effectiveness, but also for safety, because whenever you introduce a new compound, safety is very important,” Fauci said, noting that vaccines remain “our best tools against Covid-19” by preventing infection and illness, rather than treating it.

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Comments

7 Comments

  1. Good news, although it appears to be only treatment after infection, not protection from infection like the vaccines. If approved and if widely distributed, it should help reduce the hospitalization rate and the associated impacts on the health system.

  2. Wait, another EUA treatment for covid?!? Weird how studies prior to Covid-19 showed ivermectin was an effective treatment. Then Covid-19 was created and suddenly ivermectin is no good. Media warns of the danger of ivermectin, yet the media reports those with adverse reactions and even death from the vaccine “can’t be verified.” In addition to earlier studies on ivermectin, we also have irrefutable real world proof on the efficacy of ivermectin. Problem is, ivermectin does not make big pharma money.

      1. How many times has ivermectin been prescribed for human use? Has it’s safety ever been seriously called into question?

        Does Merck still hold exclusive patent to ivermectin?

        If approved, will Merck make more money off of the new drug, or Ivermectin? Which drug has a proven safety track record?

        1. Ivermectin, like all drugs, has contraindications and side effects.

          The drug is out of patent. Merck would only make money on any that it sold versus its competitors.

          The efficacy of Ivermectin against COVID remains in question. And if it is effective, what is the dosage? For how long? Do you have to quarantine? If so, for how long? We know Ivermectin has anti-viral qualities, but experiments show that effect at toxic levels to humans. More research is ongoing.

          You’re not wrong that there’s no impetus to get it approved for this in the United States. The healthcare industry here is about money, not health. And conservative politicians fight tooth and nail to keep it that way–with significant popular support, I might add.

          You’re just going to have to find a doctor who will take a chance and prescribe it to you, or you’ll have to wait until a country with a sane medical system gets more conclusive study results.

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