Merck's Oral Antiviral Molnupiravir Receives FDA Emergency Use Authorization Following Pfizer's Paxlovid

On December 23, the U.S. Food and Drug Administration granted emergency use authorization for Merck's Molnupiravir (MK-4482/EIDD-2801) to treat mild to moderate COVID-19 patients who have recently tested positive.

This is also the second oral antiviral therapy for COVID-19 that has been authorized by the U.S. FDA in just two days, following Pfizer's Paxlovid. Both oral medications are only applicable to high-risk populations who may be hospitalized or die due to severe COVID-19 and can only be obtained via prescription.

It is worth noting that these two oral medications are not interchangeable, with analysts believing Pfizer's drug outperformed Merck's in clinical trials. Molnupiravir reduced the risk of hospitalization and death in high-risk patients by 30%, while Paxlovid reduced it by nearly 90%. Molnupiravir works by introducing errors into the genetic code of the coronavirus, which first hinders and then prevents the virus from replicating.

The FDA stated that COVID-19 patients will take four 200-milligram capsules every 12 hours for five days, totaling 40 capsules. According to the FDA, similar to Paxlovid, patients should start taking Molnupiravir as soon as possible after a COVID-19 diagnosis and within five days of symptom onset. The FDA noted,Molnupiravir is not authorized for preventing COVID-19 infection in people who have been exposed to infected individuals, nor can it be taken by patients who are severely ill and hospitalized. The FDA warns that these two antiviral pills should not be considered substitutes for vaccination.

A clinical trial comparing 709 COVID-19 patients who received the drug with 699 patients who received a placebo supported the emergency approval of Molnupiravir. The FDA stated that during a one-month follow-up period, about 6.8% of people taking molnupiravir were hospitalized or died, compared to 9.7% of those receiving the placebo. This included one death in a patient taking molnupiravir and nine deaths in patients receiving the placebo.

The side effects observed in clinical trials include diarrhea, nausea, and dizziness. Molnupiravir is not authorized for use in patients under 18 years of age because it may affect bone and cartilage growth. It is also not recommended for use during pregnancy, as animal studies have shown that the drug may cause harm to the fetus.

Literature:

1.FDA Gives OK to Merck Antiviral At-Home COVID-19 Pill

Editor: Sanqi

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