European Medicines Agency (EMA) recommends using Celltrion’s Rekirona corona treatment

Celltrion announced on the 26th (local time) that the European Medicines Agency (EMA) presented an opinion recommending the use of the Corona 19 antibody treatment’Recyrona (ingredient name Regdanvimab)’ before the official product approval.

As a result, European countries can use Rekkirona based on EMA’s recommendations for use prior to formal authorization.

From the beginning of March this month, EMA has begun a review process to present professional opinions so that individual European national quarantine authorities in urgent need to use COVID-19 treatments before EMA product approval can make a decision to introduce Rekkirona through the’Compassionate Use Program. .

Accordingly, a group of experts under the EMA’s Drug User Advisory Committee (CHMP) reviewed the quality, nonclinical and clinical data of Rekirona submitted by Celltrion.

As a result, the decision was made because it was judged that the administration of Rekirona to high-risk COVID-19 patients, who are likely to be hospitalized, could lower the severe development rate and reduce the hospitalization rate.

Celltrion is already conducting preliminary consultations with individual European countries for rapid global supply of Rekirona. Based on this result, it is expected that Rekkirona’s global supply will accelerate.

In addition, we are in consultation with major regulatory agencies such as the US Food and Drug Administration (FDA) and the Organization for Economic Cooperation and Development (OECD) for Reekhirona approval, and are also striving to secure quantities for smooth supply after completion of approval in global countries. .

Celltrion has already completed the production of treatments for 100,000 people last year. According to global demand, it plans to immediately respond to supply by additionally producing 1.5 to 3 million Rekkirona per year.

Apart from this recommendation for use by country, EMA is also conducting a’rolling review’ procedure for preliminary review before official product approval from the 24th of last month.

Celltrion has already submitted the quality and manufacturing process control, nonclinical and clinical trial data required for rolling review to EMA for rapid approval of Rekirona’s items. CHMP is conducting an evaluation on the efficacy and safety of Rekirona based on various data submitted by Celltrion.

Meanwhile, the CHMP recommended that Remsima SC also approve an application for permission to change Remsima SC for indications for rheumatoid arthritis (RA), allowing immediate administration of Remsima intravenous (IV) dosage forms without pre-dosing. Until now, Remsima SC was only available after at least two doses of the IV formulation.

A Celltrion official said, “According to EMA’s recommendations for use, we will do our best to smoothly conduct prior consultations with individual countries and quickly supply treatments so that European Corona19 patients can benefit from Rekirona early on.” said.