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The FDA Will Make A Decision On Merck’s Antiviral Tablet Covid

The autumn of 2015 saw Dr. Mark Denison preparing for the long trip home from Alabama after presenting at a scientific symposium. A colleague requested him to hang around for lunch and go over some data on a possible new medicine. It was a long drive, and Dr. Denison was exhausted. When Denison was asked whether he wanted to remain, he replied yes, and now, he’s pleased he did six years later.

The FDA Will Make A Decision On Merck’s Antiviral Tablet Covid

Denison’s colleague, George Painter, is a “drug hunter” at Emory University in Atlanta, where he works as a research assistant. A novel antiviral molecule, now known as molnupiravir, was the subject of a presentation during lunch, which he shared with Denison lab personnel.

The FDA Will Make A Decision On Merck's Antiviral Tablet Covid

At the time, neither Painter nor Denison nor anyone else realized that another great possible real-world use for molnupiravir was just around the corner. Its purpose is to combat SARS-CoV-2, the virus that is responsible for Covid-19. As of November 30, molnupiravir is owned by Merck and Ridgeback Pharmaceuticals. An infectious disease advisory committee to the US Food and Drug Administration will review their clinical trial results and determine whether to recommend emergency use authorization for the drug to treat early-stage Covid-19.

According to a Merck news statement from October, the findings, which have not yet been assessed by the FDA or published in a medical journal, are extremely impressive: the tablet decreased hospitalizations and deaths by almost 50%.

However, it is unclear what type of report card will be given to that infant. Molnupiravir is a medication that operates in an unusual manner, and there are fears that it might be harmful to growing babies. Pregnant women were not included in the company’s clinical studies. DariaHazuda, who is in charge of Merck’s molnupiravir research, believes the FDA may restrict the drug’s usage in pregnant women.

In addition, there are worries that the tablet might result in the emergence of vaccine-resistant Covid-19 mutations. According to Hazuda, Merck’s study reveals that the medicine does not develop such strains. At the end of the day, the FDA and its advisors will have to evaluate the available evidence to determine if the medicine is worth the possible hazards it may pose to patients.

They should be concerned about the risks to pregnant women and the risks of developing resistance to antibiotics. However, if we have a medicine that is effective, we would want to use it. Dr. Eric Rubin, an infectious disease specialist at the Harvard T.H. Chan School of Public Health and editor in chief of the New England Journal of Medicine, said that the only thing left is to find out how to utilize it to its full potential, given its limits.

In the early phases of Covid-19, doctors are unable to provide much assistance to their patients. Although there is an FDA-approved therapy for early-Covid, monoclonal antibodies, which are administered by injections or infusions, are generally tricky for patients to get. Fortunately, Molnupiravir is a tablet that a physician may prescribe, picked up at a pharmacy, and taken at home with no difficulty whatsoever. That is why it is such a significant deal if the FDA grants approval for the medicine. The United Kingdom’s regulatory authorities authorized the medicine on November 4.

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