The European Medicines Agency presents recommendations for use by country before approval of Rekirona products
▲ At the pharmacy of Daegu Dongsan Hospital in Jung-gu, Daegu, an official is looking at Celltrion’s Corona 19 antibody treatment,’Recyronaju’. (yunhap news)
Celltrion’s new coronavirus infection (Corona 19) antibody treatment, Rekirona, has been exported to Europe.
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’Reckirona’ (developed name CT-P59, ingredient name Legdanvimab) before the official product approval. . As a result, European countries can use Rekkirona based on recommendations for use of EMA prior to formal authorization.
Earlier this month, EMA initiated a review process to present professional opinions so that individual European national quarantine authorities, who are urgently in need of the use of COVID-19 treatments before product approval, can make a decision to introduce Rekkirona through the’Passionate Use Program’. Accordingly, a group of experts under the EMA-affiliated Drug User Advisory Committee (CHMP) reviewed the quality, nonclinical and clinical data of Rekirona submitted by Celltrion.
As a result, it was judged that if Rekyrona was administered to high-risk COVID-19 patients who are likely to progress through hospitalization, it 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.
Celltrion is also in consultation with the U.S. Food and Drug Administration (FDA) and major regulators of the Organization for Economic Cooperation and Development (OECD) for Recyrona approval. Celltrion plans to produce and supply 1.5 to 3 million Rekkirona annually according to global demand.
Apart from this recommendation for use by country, EMA is proceeding with a’rolling review’ procedure for preliminary review before official product approval from February 24th.