US Merck Applies for FDA Emergency Use Authorization of Oral COVID-19 Treatment

About One-Third Cheaper Than Injection Method
Expected to Become the First FDA-Approved Oral COVID-19 Treatment Upon Approval

[Image source=AP Yonhap News]

[Asia Economy Reporter Kwon Jae-hee] U.S. pharmaceutical company Merck & Company (hereinafter Merck) has applied to the Food and Drug Administration (FDA) for emergency use authorization of an oral medication for COVID-19 treatment. It is expected to help curb the rapid spread of COVID-19 as it can be conveniently taken at home and costs about one-third less than injectable treatments. If approved by the FDA, it will be the first oral treatment for COVID-19.

According to CNBC on the 11th (local time), Merck announced that it has applied to the FDA for emergency use authorization of the oral antiviral drug "Molnupiravir" in the United States. Molnupiravir is an oral treatment for COVID-19 patients with mild to moderate symptoms who are at risk of progressing to severe illness.

Robert Davis, CEO of Merck, stated, "Due to the impact of this COVID-19 pandemic, we had to move with unprecedented urgency," adding, "Our team submitted the Molnupiravir application to the FDA within 10 days after receiving the data."

Accordingly, the FDA will closely review the safety and efficacy of Molnupiravir. The approval decision is expected within a few weeks. If the FDA grants emergency use authorization, Molnupiravir will become the first oral treatment for COVID-19.

The price per course of Molnupiravir is approximately $700 (about 830,000 KRW), which is about one-third cheaper than current injectable treatments, raising expectations that it will become a new milestone in the response to COVID-19.

Molnupiravir is taken as four capsules twice a day for five days, totaling 40 capsules. It can be conveniently taken at home, which is expected to reduce the burden on hospitals overwhelmed by COVID-19 patients and help curb the rapid spread of COVID-19 in low-income countries with shortages of medical personnel.

Merck plans to produce enough Molnupiravir for 10 million people by the end of this year. The U.S. federal government is reported to have signed a pre-purchase agreement for 1.7 million courses. Merck is also reported to be negotiating with countries including South Korea, Australia, Malaysia, and Singapore.

Merck added, "We are working with regulatory agencies to apply for emergency use and sales approval of the oral treatment in other countries within a few months."

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