European Union Commission officially approves Celltrion’s Corona treatment ‘Rekkorina’

[이코노믹리뷰=황진중 기자] On the 12th (local time), the European Union (EU) announced that Celltrion (068270) developed a COVID-19 antibody treatment ‘Lekkorona (main ingredient regdanvirab)’ and US Biotech Regeneron’s ‘Lonaprev (main ingredient imdevimab+)’ Casiribumab)’ and two other drugs were officially approved.

The European Medicines Agency (EMA) said on the same day that “Lekkorona and Lonaprev have been officially approved in the EU,” and “This is in accordance with the European Commission’s (EC) approval for the sale of these two products.”

Lekkorina became the first domestic antibody drug to obtain EU approval. Earlier, the EMA’s Drug User Advisory Committee (CHMP) recommended the approval of two types of COVID-19 antibody treatments, including Lekkorona and Lonaprev, the day before.

It is the first time that the CHMP has issued an approval recommendation for an antibody treatment for COVID-19. These treatments are expected to be administered to patients in European countries where COVID-19 is spreading at the fastest rate ever.

The target of application of Lekkorina recommended by the CHMP for approval is adults (18 years of age or older) who have confirmed COVID-19, who do not require supplemental oxygen supply and are at high risk of transitioning to severe disease. It is a method of administering the drug through an intravenous vein for 60 minutes, just like the one obtained the product approval in Korea.

Lonaprev recommends approval for use in the treatment of adults and adolescents 12 years of age and older who weigh 40 kg or more, who are at high risk of getting severe and exacerbated by COVID-19. It could also be used to prevent COVID-19 in adults 12 years of age and older, CHMP added.

Previously, the two companies applied for a formal product authorization (MAA) with the EMA in early October. At that time, the EMA said it would give its opinion within two months.