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Possibility of introducing therapeutic agents in European countries that wish to use ‘Recyrona’
The “progressive review” procedure for formal approval of articles also continues.
Celltrion announced on the 26th (local time) that the European Medicines Agency (EMA) submitted an opinion recommending the use of Corona 19 antibody treatment ‘Recyrona (ingredient legdanvimab)’ before the official approval of the product.
European countries can now use Rekirona according to EMA recommendations for use before formal authorization.
Since the beginning of last March, EMA aims to present expert opinions so that individual European national quarantine authorities who urgently need to use COVID-19 treatments before the approval of the EMA product can make the decision to introduce Rekkirona through the ‘ Compassionate Use Program ‘, etc. The review process began.
Consequently, a group of experts from the EMA-affiliated Drug User Advisory Committee (CHMP) reviewed the clinical, non-clinical and quality data for Rekirona submitted by Celltrion.
As a result, it was considered that the administration of Rekirona to high-risk corona19 patients who are likely to progress through hospitalization could reduce the rate of severe development and reduce the rate of hospitalization.
Celltrion is already conducting preliminary consultations with individual European countries for a 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 United States Food and Drug Administration (FDA) and the Organization for Economic Cooperation and Development (OECD) for the approval of Reekhirona.
Also, after approval is completed in the countries of the world, efforts are being made to secure quantities for trouble-free supply.
Celltrion already finished producing treatments for 100,000 people last year.
Celltrion plans to respond immediately to the supply by producing 1.5 to 3 million Leckirona annually, depending on global demand.
Aside from this recommendation for use by country, EMA is also proceeding with a “Continuous Review” procedure for a preliminary review prior to official product approval starting February 24 (local time).
Celltrion has already submitted the quality and manufacturing process control, non-clinical and clinical trial data required for ongoing review to EMA for rapid approval of Rekirona articles.
The CHMP is conducting an evaluation of 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 a request for authorization to switch Remsima SC for rheumatoid arthritis (RA) indications, allowing immediate administration of intravenous (IV) dosage forms of Remsima without prior medication. Until now, Remsima SC was only available after at least two doses of the intravenous formulation.
A Celltrion official said: “In accordance with the EMA’s recommendations for use, we will do our best to proceed smoothly with prior consultations with individual countries and rapidly deliver treatments so that European Corona19 patients can benefit from Rekirona from the beginning. beginning”.
He added: “If Remsima SC can be administered immediately without a pre-dosing of the intravenous formulation, the ease of administration for RA patients in Europe is expected to greatly improve.”
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