Merck Asks FDA to Authorize COVID-19 Antiviral Pill

Merck Asks FDA to Authorize COVID-19 Antiviral Pill

Drugmaker Merck on Monday announced that it has applied to the Food and Drug Administration for emergency use authorization of its COVID-19 antiviral pill.

If authorized, it would be the first pill to gain the regulatory OK to treat COVID-19. The company wants to use the pill for “mild-to-moderate COVID-19 in adults who are at risk for progressing to severe COVID-19 and/or hospitalization.”

Merck reported earlier this month that its drug, called molnupiravir, cut the risk of hospitalization and death from COVID-19 in half.

More than 7% of patients who received the drug were either hospitalized or died through nearly a month of the trial, compared to 14% of people who received the placebo, according to the company. No deaths were reported in trial participants who received the pill, while eight people who received the placebo died.

The results were so positive that the company was able to stop its trials early.

“The submission to the FDA is a critical step towards making molnupiravir available to people who may benefit from an oral antiviral medicine that can be taken at home shortly after diagnosis with COVID-19,” Wendy Holman, CEO of Ridgeback Biotherapeutics, which partnered with Merck on the pill, said in a statement.

Merck said that it expects to produce 10 million courses of the treatment by the end of the year.

The U.S. government has agreed to buy about 1.7 million courses of the drug for approximately $1.2 billion, pending FDA emergency use authorization…Read more>>