Celltrion(300,000 +2.92%)The European Medicines Agency (EMA) announced on the 3rd that it has begun a review process to provide expert opinions to European countries that want to introduce the Corona 19 antibody treatment Rekirona early.
Individual countries in Europe may use Rekirona through the Compassionate Use Program before the EMA product permit is granted. At this time, experts from the Drug User Advisory Committee (CHMP) under the EMA offer scientific opinions on whether Rekirona can be used.
The review will be conducted based on the clinical data of Celltrion, which was conducted in patients with moderate to severe corona19 and high-risk patients. EMA plans to verify whether Rekirona can reduce the rate of severe development as a treatment for COVID-19 and reduce the rate of visits and hospitalizations in intensive care facilities.
This review is separate from the rolling review process before application for permission. Celltrion submitted quality and manufacturing process control data, and non-clinical and clinical data to EMA in order to expedite Rekirona’s product approval. From the 24th of last month, EMA began evaluating the efficacy and safety of Rekirona based on various data submitted by Celltrion.
The company is preparing for smooth supply after the expedited approval process is completed. Completed production of Rekkirona for 100,000 people. Depending on the demand, it plans to produce 1.5 to 3 million Rekkirona additionally per year.
Reporter Park In-hyuk [email protected]
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