"Surge in Confirmed Cases" ... Emergency Approval Review for Oral Antiviral 'Molnupiravir'

MFDS "Need to Secure Additional Options for High-Risk Patients"

Merck's COVID-19 Pill Treatment 'Molnupiravir' Approved by US FDA
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[Asia Economy Reporter Jo In-kyung] The government is considering the emergency approval of the oral COVID-19 treatment 'Molnupiravir' developed by Merck & Company (MSD).

On the 20th, the Ministry of Food and Drug Safety (MFDS) stated, "Due to the surge in COVID-19 patients, we are carefully reviewing the necessity of emergency use authorization for additional treatment options for high-risk mild to moderate patients who find it difficult to use 'Paxlovid' and 'Remdesivir.'

Regarding the timing of the emergency use approval, the MFDS said, "It is difficult to predict whether or when approval will be granted."

Previously, the government completed a pre-purchase contract to import enough Molnupiravir for 242,000 people from MSD. The MFDS began reviewing the emergency use approval for this drug on November 17 last year, but approval was withheld after clinical trials showed only about a 30% effect in preventing hospitalization and death in high-risk mild to moderate patients.

However, with the recent Omicron surge causing a rapid increase in demand for oral treatments, the government aims to secure other products besides Pfizer's 'Paxlovid,' which is currently in use.

Molnupiravir and Paxlovid both help prevent high-risk mild to moderate patients from worsening to severe conditions, but the target patient groups and criteria differ slightly. Therefore, the government appears to be considering primarily using Paxlovid, which has an 88% effect in preventing hospitalization and death, while supplementing with Molnupiravir for patients who cannot be prescribed Paxlovid.

The government's pre-purchase quantity of Paxlovid is for 762,000 people, with 163,000 doses already imported. The cumulative usage is 74,514 doses, and although there is still a surplus, about half of the usage occurred within the past week, raising concerns about depletion.

In response to the increased demand for Paxlovid, the government is considering early import of the contracted quantity as well as additional purchases.

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