MSD Oral Treatment, Emergency Use Authorization Application Submitted to MFDS

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[Asia Economy Reporter Chunhee Lee] MSD (Merck)'s oral antiviral treatment 'Molnupiravir' has been submitted for emergency use authorization in South Korea.

On the afternoon of the 17th, at a press conference held at the Ministry of Food and Drug Safety (MFDS) in Osong, Chungbuk, Kim Gang-lip, the head of MFDS, stated, "Just a moment ago, the emergency use authorization application for MSD's Molnupiravir was received at the request of the Korea Disease Control and Prevention Agency." He added, "Although there will be some restrictions, we plan to review the data on safety and efficacy and proceed with expert consultations and other procedures to make a final decision regarding the emergency use authorization."

Regarding Pfizer's oral antiviral treatment 'Paxlovid,' a preliminary review is currently underway. Park Yoon-joo, director of the Pharmaceutical Evaluation Department at MFDS, said, "Although an emergency use authorization application has not been submitted for Pfizer's oral antiviral treatment, we are conducting a preliminary review of quality and clinical data." The preliminary review process is a step where regulatory authorities verify any necessary supplements based on data obtained before the product approval or emergency use authorization application.

Concerning the introduction timeline of oral antiviral treatments set by health authorities for early next year, Kim explained, "If positive results come from expert consultations or review procedures, completing the process within this year is quite feasible," and added, "Afterward, there should be no significant issues with the importation and on-site use of the pharmaceuticals domestically as the process proceeds."

Regarding domestic antiviral treatments, Kim emphasized that efficacy is the key factor. He said, "There are products that repurpose existing drugs, and some have already been approved," suggesting that safety is not expected to be a major issue. However, he noted, "We have not yet found any products that meet the level of conditional approval without conducting phase 3 clinical trials in terms of efficacy." Nevertheless, Kim stated, "Some effects identified through phase 3 trials are worth further verification," and concluded, "Our evaluation of domestic oral antiviral treatments is that a final judgment should be made after reviewing the phase 3 results."

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