What Kind of Drug Is 'Evusheld,' the COVID Antibody Treatment Under Domestic Introduction Review?

Direct Antibody Injection for Immunocompromised and Vaccine Adverse Reaction Patients
US Study Shows "Effective Against Omicron and Stealth Omicron"

[Image source=AP Yonhap News]

[Asia Economy Reporter Kim Young-won] The quarantine authorities are considering the domestic introduction of AstraZeneca (AZ)'s COVID-19 antibody agent 'Evusheld' (active ingredients tixagevimab and cilgavimab).

On the 23rd, the Central Disease Control Headquarters confirmed, "We are reviewing whether to request domestic approval of Evusheld from the Ministry of Food and Drug Safety." The headquarters also announced on the 23rd of last month that it was considering the introduction of Evusheld to protect immunocompromised individuals.

Regarding this, a representative from Korea AstraZeneca said, "We understand that the quarantine authorities have been continuously reviewing the approval of Evusheld," adding, "It is difficult to say at which official stage it currently is."

Evusheld is an antibody agent intended for 'prevention' by directly administering antibodies into the body via injection. This differs from oral antiviral treatments like Paxlovid and Lagevrio, which target patients infected with COVID-19. It is mainly administered to severely immunocompromised individuals who have difficulty forming antibodies even after vaccination or those who have experienced adverse reactions to vaccines. The monoclonal antibodies tixagevimab and cilgavimab are each contained in separate ampoules and packaged together, administered sequentially via intramuscular (IM) injection. It is known to provide disease prevention effects within four hours after administration.

The quarantine authorities expect that if Evusheld is introduced, it will contribute to preventing infections among high-risk COVID-19 groups such as immunocompromised individuals. The number of immunocompromised people in Korea is estimated to be about 1.3 million. In a Phase 3 clinical trial involving 5,197 immunocompromised and cancer patients, the group receiving Evusheld showed approximately a 77% reduction in the risk of developing COVID-19 compared to the placebo group.

Furthermore, unlike other antibody treatments, Evusheld has been confirmed to be effective against Omicron and its subvariants. Preclinical results conducted by the University of Washington School of Medicine using live viruses revealed that Evusheld maintains neutralizing activity against the Omicron variant and the BA.2 variant, also known as stealth Omicron. The domestically produced antibody treatment 'Rekkironaju' has unclear efficacy against the Omicron variant, leading to a suspension of new supplies since the 18th of last month. For the same reason, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization of Eli Lilly and Regeneron antibody treatments in January.

Overseas countries are permitting or increasing the introduction of Evusheld. The FDA approved Evusheld in December last year and purchased an additional one million doses in February. On the 17th of this month, the UK Medicines and Healthcare products Regulatory Agency (MHRA) also approved Evusheld. Currently, the raw materials for Evusheld are produced by Samsung Biologics in Korea and supplied to AZ.

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