Celltrion Applies to Expand COVID-19 Treatment 'Rekkirona' Use to All Mild Patients

[Asia Economy Reporter Seo So-jeong] The Ministry of Food and Drug Safety announced on the 11th that it has begun reviewing Celltrion's application to expand the treatment indication of the COVID-19 antibody therapeutic 'Rekkirona' (generic name Regdanvimab) to include all mild and moderate patients aged 12 and older.

Celltrion also applied for a change to shorten the drug administration time from 90 minutes of intravenous infusion to 60 minutes of intravenous infusion.

Previously, the Ministry conditionally approved Rekkirona for use only in high-risk mild cases and all moderate adult COVID-19 patients. High-risk mild cases include those aged 60 and above, patients with cardiovascular disease, chronic respiratory disease, diabetes, and hypertension.

Celltrion submitted the report of the confirmatory therapeutic clinical trial results, which was a condition attached at the time of Rekkirona's approval, on the 10th of this month.

The Ministry of Food and Drug Safety stated, "We plan to review this change application promptly and thoroughly," adding, "We will continue to do our best to quickly supply safe and effective therapeutics to our people."

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