US FDA Approves Merck-Developed Oral COVID-19 Treatment

Second Approval Following Pfizer Pill
Low Efficacy and Side Effects Raise 'Question Marks' on Actual Prescriptions

[Image source=Reuters Yonhap News]

[Asia Economy New York=Correspondent Baek Jong-min] The U.S. Food and Drug Administration (FDA) has granted emergency use authorization for Merck's COVID-19 oral antiviral treatment, Molnupiravir. The FDA approved oral COVID-19 treatments for two consecutive days, actively responding to the rapid surge in Omicron variant infections.

On the 23rd (local time), the FDA authorized the use of Molnupiravir for patients who tested positive for COVID-19 and exhibit symptoms ranging from mild to severe.

Molnupiravir is the second COVID-19 treatment pill available for home use, following Pfizer's Paxlovid, which was approved by the FDA the day before.

Molnupiravir has been found to reduce the risk of hospitalization or death by 30% in high-risk adults. Initially, a 50% effectiveness was expected, but this was later revised downward.

While Paxlovid can be taken by patients aged 12 and older, Molnupiravir is only authorized for patients aged 18 and older due to potential effects on bone growth.

Ellyab Bar, Senior Vice President of Global Medical Affairs at Merck, expressed optimism that Molnupiravir will be effective against the Omicron variant.

The FDA appears to have expedited treatment approvals in response to the rapid spread of the Omicron variant, especially in the northeastern regions.

Patricia Cavazzoni, Director of the FDA's Center for Drug Evaluation and Research, stated, "As new variants continue to emerge, it is important to expand the arsenal of COVID-19 treatments."

Merck has a supply contract with the U.S. government for 3.1 million doses of Molnupiravir.

The Associated Press reported that although the FDA approved Molnupiravir, some experts predict that doctors may be hesitant to prescribe it due to side effects and its lower efficacy compared to Paxlovid.

Merck set eligibility criteria for participation in Molnupiravir clinical trials, including restrictions on sexual activity for four days after the last dose and a prohibition on pregnancy for women. Medical experts interpret this as indicating a potential risk of congenital malformations if pregnancy occurs during the treatment period.

This content was produced with the assistance of AI translation services.