Celltrion's 'Rekkirona' Receives Recommendation for Approval of Use in Europe

European Medicines Agency's Drug Utilization Advisory Committee 'Approval Recommendation'
Practical Approval Imminent in Europe

'Inhalation' Clinical Trials Also Underway in Australia

Celltrion COVID-19 Antibody Treatment 'Rekkirona' (Photo by Celltrion)

[Asia Economy Reporter Lee Chun-hee] Celltrion's COVID-19 antibody treatment 'Rekkirona (CT-P59, generic name 'Regdanvimab')' is expected to be approved in Europe.

On the 11th (local time), Celltrion announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has made a 'recommendation for approval' decision for Rekkirona. The CHMP recommended approval for two antibody treatments, Rekkirona and Regeneron's antibody treatment 'Ronapreve'.

The target patients for Rekkirona are adults aged 18 and over infected with COVID-19. These are patients who do not require supplemental oxygen but are at high risk of progressing to severe disease. The recommendation for approval was given for intravenous administration over 60 minutes, the same as the domestic product approval.

CHMP approval is effectively interpreted as European drug approval. As an organization that provides opinions on approval to the EMA, the European Commission (EC) usually announces the formal product approval within 1 to 2 months after receiving CHMP's opinion.

Celltrion had previously submitted a formal marketing authorization application (AMA) to the EMA in early last month. The CHMP recommended approval for Rekkirona through a rolling review (a pre-approval review process) in just over a month.

Incheon Songdo Celltrion Plant 2 Overview. / Incheon - Photo by Hyunmin Kim kimhyun81@

Rekkirona obtained emergency use authorization from Indonesia's National Agency of Drug and Food Control (BPOM) in July and from Brazil's National Health Surveillance Agency (ANVISA) in August. In September, it also received formal marketing authorization from South Korea's Ministry of Food and Drug Safety. According to the Central Disease Control Headquarters, as of the 4th, Rekkirona has been administered to 21,366 patients at 127 hospitals.

Celltrion plans to accelerate the development of inhaled Rekkirona, which has entered clinical trials in Australia. This method delivers antibodies to the airway mucosa by inhalation, significantly improving dosing convenience compared to the current intravenous infusion over 60 minutes. Additionally, it is expected to become a more cost-effective alternative in countries with high medical service costs, as home treatment without hospital visits will be possible.

A Celltrion official said, "Rekkirona is a culmination of advanced antibody technology, having completed domestic substance patent registration and worldwide substance patent applications," adding, "With this CHMP approval recommendation, the path has opened to actively use Rekkirona for COVID-19 treatment in Europe." He continued, "If the development of inhaled Rekkirona succeeds, it will be possible to provide the proven efficacy and safety of antibody treatments to more patients at a cost-competitive price compared to other treatment methods."

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