COVID-19 Oral Antiviral 'Lagevrio' Emergency Approval... "Increased Treatment Options for High-Risk Groups" (Comprehensive)

Excluding Pregnant Women and Children Under 18
Hospitalization and Death Prevention Effect 30%, Half of Paxlovid's (88%)
Experts Say "Meaningful Increase in Treatment Options for High-Risk Groups"

[Asia Economy Reporter Ki Ha-young] The Ministry of Food and Drug Safety (MFDS) has decided to grant emergency use authorization for the oral COVID-19 treatment 'Lagevrio' (active ingredient Molnupiravir), developed by the U.S. company Merck.

On the 23rd, the MFDS announced that it had decided to grant emergency use authorization for Lagevrio after deliberation by the 'Public Health Crisis Response Medical Products Safety and Supply Committee.' This decision comprehensively considered the need for alternative treatments for high-risk mild to moderate patients who find it difficult to use existing treatments amid the rapid surge in COVID-19 cases, the MFDS's review of safety and efficacy, and expert advisory meeting results.

Exclusion of Pregnant Women and Children/Adolescents Under 18

Lagevrio is the second oral treatment introduced domestically. The target patients are adults with mild to moderate COVID-19 who are at high risk of progressing to severe illness, such as the elderly or those with underlying conditions.

Paxlovid is currently used for those aged 60 and over, immunocompromised individuals, and those aged 40 and above with underlying conditions, but it has many contraindicated drug interactions and requires caution when administered to patients with impaired kidney or liver function.

Therefore, the MFDS expects that Lagevrio will help prevent patients from worsening to severe illness when injectable treatments are difficult to use and Paxlovid cannot be taken.

However, Lagevrio cannot be administered to pregnant women and children/adolescents under 18 years old. This decision was made considering concerns about fetal development effects observed in animal studies, abnormalities in bones and cartilage, and the lack of clinical trials in adolescents.

Nursing mothers, women of childbearing potential, and men should exercise caution when taking the drug. Nursing mothers are advised not to breastfeed during treatment and for 4 days after the last dose; women of childbearing potential need contraception for 4 days after the last dose, and men need contraception for 3 months.

30% Prevention Effect on Hospitalization and Death... Experts Say "Meaningful Increase in Options for High-Risk Groups"

When prescribed Lagevrio, patients should take 800 mg per day (four 200 mg capsules) twice daily (every 12 hours) for 5 days. It is recommended to start treatment as soon as possible within 5 days after testing positive for COVID-19 and symptom onset.

In the final clinical trial results, Lagevrio showed a 30% prevention effect on hospitalization and death, which is less than half the effect of Paxlovid (88%). Regarding this, Professor Choi Won-seok of Korea University Ansan Hospital's Department of Infectious Diseases said at an MFDS briefing, "It may be difficult to say the prevention effect is very high," but added, "For patients who cannot take existing treatments due to underlying diseases or concomitant medications, having an option for high-risk groups is significant."

Clinical trials confirming treatment efficacy after infection with Omicron or its subvariant stealth Omicron (BA.2) have not been conducted. However, in vitro (test tube) experiments have shown effectiveness against variants.

Regarding concerns that Lagevrio may cause cancer, congenital genetic disorders, or birth defects, Professor Son Woo-chan of Seoul Asan Hospital's Department of Pathology explained, "Some positive results were observed in genotoxicity tests, but a single test result alone does not determine genotoxicity," and added, "It is reasonable to avoid risks by restricting use."

MFDS Plans to Provide Lagevrio Guidebook

Following this emergency use authorization, the MFDS plans to thoroughly collect adverse event information and implement additional safety measures during the use of Lagevrio. The domestic importer is required to collect and report domestic and international safety information, and a system has been established for medical professionals and patients (families) to report adverse events via phone or online. If serious adverse events occur, causality will be evaluated and compensation provided.

Additionally, the Drug Utilization Review (DUR) system used by medical professionals during prescription and dispensing will notify that Lagevrio cannot be used for pregnant women and children/adolescents under 18, and provide cautionary information for women and men planning pregnancy and nursing mothers.

An MFDS official stated, "In cooperation with the Ministry of Health and Welfare, the Korea Disease Control and Prevention Agency, and the Korean Pharmaceutical Association, we plan to provide a guidebook necessary for safe use to patients (caregivers) using Lagevrio," and added, "We will strictly manage to ensure that it is not prescribed or administered to excluded patients such as pregnant women and children/adolescents under 18."

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