The European Medicines Agency (EMA) is reviewing the possibility of urgent use of Celltrion’s Corona 19 antibody treatment drug’Recyrona’ (ingredient name Legdanvimab).
Celltrion announced on the 3rd that EMA has undertaken a review process to provide expert opinions to European countries that want to introduce Rekirona early.
In this review, a group of experts from the Drug User Advisory Committee (CHMP) under the EMA presented scientific opinions on the availability of Rekirona so that the quarantine authorities in European countries who want to quickly secure Rekirona can make a decision to introduce them even before the EMA item is approved. This is the procedure to do.
The expert group is evaluating the clinical data of Celltrion in patients with moderate corona19 disease and high-risk patients who are at high risk of progressing to hospitalization. It is planned to verify whether Rekirona relieves the condition of the Corona 19 patient and prevents it from getting worse.
On the 24th of last month, EMA entered a special procedure called a companion review (rolling review) to quickly determine whether or not to approve Rekkirona. EMA is evaluating the quality and manufacturing process control, nonclinical and clinical trial data submitted by Celltrion.
Celltrion said it is ready to supply as soon as it receives EMA approval. It has already produced 100,000 servings for domestic patients, and plans to produce 1.5 to 3 million additional servings per year depending on demand.
Reporter Oh Sang-heon [email protected]
Ⓒ Hankyung.com prohibits unauthorized reproduction and redistribution