Celltrion’s novel coronavirus infection (Corona 19) antibody treatment,’Recyrona (ingredient name Reddanbimab)’ has passed the first gateway to enter the European market.
The European Medicines Agency (EMA) announced on the 26th (local time) that it recommended the use of Celltrion Rekirona.
According to this recommendation to use EMA, European countries can decide whether to introduce Rekirona through the’Compassionate Use Program’ before receiving formal product approval from the EU.
On the 26th, EMA posted on its website, “The EMA Drug User Advisory Committee (CHMP) has completed a review of the use of the antibody treatment Rekirona (codename CT-P59) for the treatment of COVID-19 patients. “Rekirona could be used for the treatment of adult patients who are at high risk of progressing to.
Earlier, on the 2nd, EMA initiated the CHMP review process to present expert opinions to individual European countries that want to introduce Rekirona early. To this end, Celltrion submitted data to the Rekkirona Global Phase 2 to EMA.
In this context, EMA explained that “this review provided scientific opinions at the EU level to assist individual countries in making decisions about the use of antibody treatments prior to product approval.”
“Research data suggests that Rekirona may lower hospitalization rates,” EMA said. “There is insufficient evidence to draw a solid conclusion about the benefits of the drug.” In terms of safety, most side effects were reported in mild or moderate patients.”
“Infusion-related reactions, including allergic reactions, cannot be ruled out, and medical professionals should monitor patients for these reactions,” EMA stressed.
However, EMA said, “Despite the uncertainty, CHMP may be considered a treatment option for patients at high risk of developing Rekirona to severe COVID-19 based on the reasonable likelihood and low risk likelihood that the drug will provide a clinical benefit. “I concluded.
In addition, EMA has been conducting a’Rolling Review’ on Rekkirona from last month.
Rolling Review is a system used by CHMP to accelerate the evaluation of treatments or vaccines in crisis situations such as pandemics. First of all, it is a method of reviewing.
On that day, EMA explained, “A rolling review of Rekirona, which started on February 24, is currently in progress,” and “when the final review is completed, it will be the basis for the application for EU approval for the drug.”