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Merck Asks US FDA for an Emergency Use Authorization of Its COVID-19 Antiviral Pill

WASHINGTON (AP) — Merck has asked US authorities to approve its promising COVID-19 antiviral pill, paving the way for a decision in the coming weeks. If approved by the Food and Drug Administration, it would be the first drug shown to treat COVID-19, providing a new, simple weapon to the world's arsenal against the epidemic. (Photo: WBNG)

Merck & Co. confirmed on Monday that it had submitted an emergency use application to the US Food and Drug Administration for the first antiviral tablet to target COVID-19.

If Merck’s drug application will have the greenlight, the antiviral pill will be the first to treat Covid-19. (Photo: Mel Evans)

In a recently published aricle in The New York Times, experts believe that the approval of molnupiravir, which is currently only approved for use in high-risk Americans, could be a significant step forward in the fight against COVID-19. Because a more convenient, less expensive treatment could reach many more high-risk patients than the more complicated monoclonal antibody treatments currently in use.

In a statement announcing the application, Merck CEO and President Robert Davis remarked, “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.” He continues to say, “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

Merck Medication Cut Hospitalizations In Half Among Unvaccinated High-Risk Persons

The Biden administration has already placed an advance order for enough of the medicine to treat 1.7 million Americans at around $700 per patient, which is about one-third the cost of intravenous antibody therapies. Merck aims to generate enough molnupiravir for 10 million people by the end of the year, the Times reported.

Furthermore, according to senior White House officials, the federal government will likely ship the pills to states, which will then decide how to distribute them to patients, as it did with vaccines. On the other hand, conforming to the statements in the Times, the Merck medication cut hospitalizations in half among unvaccinated high-risk persons who developed COVID-19 symptoms within the previous five days in clinical studies, per USA News.

People would take four pills twice a day for five days at home with molnupiravir. Hence, according to a company representative, the FDA would have to decide whether the medication would be available to vaccinated persons who were not qualified for the clinical trial.

Pfizer and Atea Pharmaceuticals-Roche are also working on COVID-19 antiviral tablets, per The New York Times.

 

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