MFDS Grants Emergency Use Authorization for COVID-19 Oral Treatment 'Lagevrio'

Exclusion of Pregnant Women and Children/Adolescents Under 18
MFDS to Collect Side Effects and Provide Guidance Documents

[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 necessity of treatment alternatives for high-risk mild to moderate patients who find it difficult to use existing treatments amid the rapid increase in COVID-19 cases, the MFDS's review of safety and efficacy, and expert advisory meeting results.

Lagevrio Excluded for Pregnant Women and Children/Adolescents Under 18

Lagevrio is the second oral treatment introduced domestically. It is an RNA analog drug that induces virus elimination by being incorporated instead of RNA during the replication process of the COVID-19 virus.

It is intended for use in mild to moderate adult patients at high risk of progressing to severe COVID-19 due to age, underlying diseases, and other factors. It is only to be used for patients who cannot use other COVID-19 treatments or for whom other treatments are clinically inappropriate. However, pregnant women and children/adolescents under 18 years old are excluded from the target patients for administration.

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

Internationally, conditional approvals or emergency use authorizations have been granted in 15 countries including the United Kingdom, the United States, and Japan.

MFDS Plans to Provide Lagevrio Guidance

Earlier, on November 17 last year, the Korea Disease Control and Prevention Agency (KDCA) requested emergency use authorization for Lagevrio from the MFDS. The MFDS reviewed submitted non-clinical and clinical trial results, quality data, and received advice from 11 external experts in infectious diseases, toxicology, virology, and other fields.

The advisory results concluded that considering the domestic COVID-19 pandemic situation comprehensively, the necessity for emergency use authorization of Lagevrio was recognized. However, based on animal and clinical trial data reviews, it was recommended to restrict the target patient group by excluding pregnant women and children/adolescents under 18. The Public Health Crisis Response Medical Products Safety and Supply Committee also acknowledged the validity of emergency use authorization considering expert advice and the increasing number of domestic COVID-19 cases.

Following this emergency use authorization, the MFDS plans to thoroughly collect adverse event information and implement additional safety measures during Lagevrio’s use. The domestic importer will be required to collect and report safety information both domestically and internationally, and a system has been established allowing healthcare professionals and patients (or their families) to report adverse events via phone or online. In case of serious adverse events, causality will be assessed and compensation provided accordingly.

Additionally, through the Drug Utilization Review (DUR) system used by healthcare professionals during prescription and dispensing, Lagevrio will be flagged as not to be used in pregnant women and children/adolescents under 18, and precautionary information will be provided for women and men planning pregnancy as well as breastfeeding mothers.

An MFDS official stated, "In cooperation with the Ministry of Health and Welfare, KDCA, and the Korean Pharmaceutical Association, we plan to provide guidance necessary for the safe use of Lagevrio to patients (and their guardians). 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.