Celltrion Obtains Conditional Approval for Antibody Treatment 'Rekkirona' in Peru

[Asia Economy Reporter Seo So-jeong] Celltrion announced on the 22nd that its COVID-19 antibody treatment 'Rekkirona' (generic name Regdanvimab) received conditional approval for use from the Peruvian Medicines Regulatory Authority (DIGEMID) on the 16th (local time).

The Peruvian Medicines Regulatory Authority performs functions similar to the Korean Ministry of Food and Drug Safety, and all medicines distributed in Peru must obtain product approval from this authority.

According to the COVID-19 real-time statistics site Worldometer, as of this date, Peru's cumulative COVID-19 confirmed cases have surpassed 2.2 million, and cumulative deaths have exceeded 200,000. Currently, daily confirmed cases are around 1,700 and deaths about 30, raising high alert over further spread of COVID-19.

Rekkirona obtained emergency use authorization from Indonesia's Food and Drug Monitoring Agency (BPOM) and Brazil's National Health Surveillance Agency (ANVISA) in July and August, respectively, and received formal product approval from Korea's Ministry of Food and Drug Safety and Europe in September and November. Additionally, as of the 18th according to the Central Disease Control Headquarters, it has been administered to 23,781 patients in 130 hospitals nationwide.

A Celltrion official stated, "Rekkirona confirmed safety and efficacy through global Phase 3 clinical trials involving 1,315 mild to moderate COVID-19 patients across 13 countries including Korea, the United States, Spain, and Romania," adding, "Among high-risk patients treated with Rekkirona, the incidence of severe cases decreased by 72% compared to the placebo group, and the time to clinical symptom improvement was shortened by more than 4.7 days compared to the placebo group in high-risk patients."

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