FDA Panel Narrowly Recommends Use Of Merck's Covid-19 Pill

An advisory panel to the Food and Drug Administration or FDA on Tuesday scarcely voted to recommend the authorization of Merck & Co's (MRK) antiviral pill to treat COVID-19.

If the FDA gives the green signal to the drug, it would be the first at-home treatment for the virus, almost two years after the pandemic started. The authorization would mostly be limited to patients who are at high risk of developing severe disease, although the exact population would be decided by the FDA.

Commenting on the decision, advisory panel member Dr David Hardy said, "COVID-19 is still an emergency situation. There is a need for something like this. This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available, although I do have questions about its overall longer-term efficacy."

Last week, Merck released data that the drug was not that effective as it had been projected earlier, reducing hospitalizations and deaths in its clinical trial of high-risk individuals by around 30%.

The FDA vote comes in the backdrop of the new Omicron variant spreading across the world and creating ripples in the financial markets, which is slowly emerging from the pandemic-induced restrictions and lockdowns.

Merck's drug called molnupiravir, developed in association with Ridgeback Biotherapeutics, targets part of the virus called the RNA polymerase that has not been changed much by mutations in the Omicron variant. The pill could become even more vital if vaccine-induced and natural immunity cannot stop the virus.

The FDA's Antimicrobial Drugs Advisory Committee voted 13-10 to recommend the authorization of the drug after discussing concerns that it could cause the virus to mutate as well as safety concerns about the potential for birth defects. Both FDA staff scientists and Merck have suggested the drug should not be recommended during pregnancy.

Several members said the reduced number of COVID-related deaths in people who received the drug in the trial convinced them to vote in favor of recommending authorization. Only one patient in the molnupiravir arm died, versus nine in the placebo group.

Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022.

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