Possible to introduce therapeutic agents to European countries that wish to use’Recyrona’
The’rolling review’ procedure for formal item approval is also continuing.
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’Recyrona (ingredient legdanvimab)’ before the official product approval.
European countries are now able to use Rekirona based on EMA’s recommendations for use prior to formal authorization.
From the beginning of last March, EMA is aiming to present expert opinions so that individual European national quarantine authorities in urgent need to use COVID-19 treatments before EMA product approval can make a decision to introduce Rekkirona through the’Compassionate Use Program’. Started the review process.
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 the administration of Rekirona to high-risk corona19 patients who are likely to progress through hospitalization 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.
Celltrion believes that the global supply of Rekkirona will accelerate based on this result.
Celltrion is also in negotiations with major regulatory agencies such as the US Food and Drug Administration (FDA) and the Organization for Economic Cooperation and Development (OECD) for Reekhirona approval.
In addition, after approval in global countries is completed, efforts are being made to secure quantities for smooth supply.
Celltrion has already finished producing treatments for 100,000 people last year.
Celltrion plans to immediately respond to supply by producing 1.5 to 3 million Leckirona annually depending on global demand.
Apart from this recommendation for use by country, EMA is also proceeding with a’Rolling Review’ procedure for preliminary review before official product approval from February 24 (local time).
Celltrion has already submitted the quality and manufacturing process control, nonclinical and clinical trial data required for rolling review to EMA for rapid approval of Rekirona’s items.
CHMP is conducting an evaluation on the efficacy and safety of Rekirona based on various data submitted by Celltrion.
On the other hand, the CHMP recommended that Remsima SC also approve an application for permission to change Remsima SC for indications for rheumatoid arthritis (RA), allowing immediate administration of Remsima intravenous (IV) dosage forms without pre-medication. Until now, Remsima SC was only available after at least two doses of the IV formulation.
An official from Celltrion said, “According to EMA’s recommendations for use, we will do our best to smoothly proceed with prior consultations with individual countries and quickly supply treatments so that European Corona19 patients can benefit from Rekirona early on.” said.
He added, “If Remsima SC can be administered immediately without pre-dosing of IV formulation, it is expected that the ease of administration of RA patients in Europe will be greatly improved.”
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