MFDS Initiates Emergency Use Authorization Process for MSD Oral Treatment (Comprehensive)

[Image source=Reuters Yonhap News]

[Asia Economy Reporter Lee Chun-hee] MSD's oral antiviral drug Lagevrio (active ingredient 'Molnupiravir') has been submitted for emergency use authorization in South Korea. Preliminary review is underway for Pfizer's oral antiviral drug Paxlovid.

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

Lagevrio is an RNA analog that works by being incorporated instead of normal ribonucleic acid during the viral replication process, thereby inducing viral death. The MFDS will thoroughly review the submitted clinical and quality data, hold expert advisory meetings, and conduct deliberations by the 'Public Health Crisis Response Medical Product Safety Management and Supply Committee' to confirm the product's safety and efficacy before deciding on emergency use authorization.

Regarding Pfizer's oral antiviral drug Paxlovid, a preliminary review is in progress. Park Yoon-joo, Director of the Pharmaceutical Evaluation Division at MFDS, said, "Although an emergency use authorization application has not been submitted for Pfizer's oral antiviral drug, we are conducting a preliminary review of the quality and non-clinical data."

Paxlovid inhibits the 3CL protease, an essential proteinase for viral replication, thereby suppressing the proliferation of the COVID-19 virus.

Earlier, on the 10th, Korea Pfizer applied for a preliminary review of the quality and non-clinical data for Paxlovid. The preliminary review process is a step where regulatory authorities verify any supplementary requirements based on the data secured before the product approval or emergency use authorization application. The MFDS will carefully conduct a preliminary review of the submitted quality and non-clinical data and, if the KDCA requests emergency use authorization, will promptly proceed with the approval process.

[Image source=Reuters Yonhap News]

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

Commissioner Kim emphasized that efficacy is the key factor for domestically developed treatments. He stated, "There are products that repurpose existing drugs, and some have already been approved," and while he believes there are no major safety concerns, 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." However, Commissioner Kim added, "Some effects identified through Phase 3 trials are worth further verification," and concluded, "Our evaluation of domestic oral antiviral drugs is that a final judgment should be made after reviewing the Phase 3 results."

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