Celltrion’Rekirona’ initiates emergency use review before European approval

Celltrion announced on the 3rd that the European Medicines Agency (EMA) has begun a review process to provide expert opinions to European countries that want to introduce the Corona 19 antibody treatment’Recyrona’ early.

This review is a separate procedure from the Rolling Review, which began on February 24 (local time). A group of experts under the CHMP under the EMA can help quarantine authorities in individual countries in Europe where the introduction of Rekirona is urgently applied through the’Compassionate Use Program’, etc. It is intended to present a scientific opinion on whether it is possible to use Rekyrona.

This review is based on Celltrion’s clinical data for patients with moderate corona19 disease and high-risk patients who are at high risk for hospitalization. EMA plans to verify whether Rekirona can reduce the rate of severe development as a treatment for COVID-19 and reduce the rate of visits and hospitalizations in intensive care facilities.

On the other hand, Celltrion has already submitted quality and manufacturing process control, non-clinical and clinical trial data to EMA in order to proceed with rapid product approval of Rekkirona through rolling review, and CHMP has been submitted by Celltrion since February 24th. Based on various data, we started to evaluate the efficacy and safety of Rekirona.

Celltrion is also making progress in securing quantities for smooth supply immediately after completing the global rapid approval process. It has already completed production for 100,000 people, and plans to additionally produce 1.5 to 3 million people per year, depending on demand, so as to respond to immediate supply.