The company announced on the 25th that the European Medicines Agency (EMA) has initiated a companion review (rolling review) for the Corona 19 antibody treatment’Recyrona’ (ingredient name regdanvimab) developed by Celltrion.
The companion review is a procedure to expedite the evaluation of a treatment or vaccine in a crisis situation such as an infectious disease pandemic. EMA reviews data on efficacy, safety, and quality of drugs through a companion review before receiving an application for product approval. The EMA-affiliated Drug User Advisory Committee (CHMP) began evaluating the quality of Rekirona based on the results from animal studies and clinical phases 1 and 2.
Celltrion is also undergoing preliminary consultations with the US Food and Drug Administration (FDA) for product approval. Due to the difficulty in recruiting patients and supply of vaccines, the clinical trial that tried to develop Rekirona for the purpose of preventing COVID-19 was decided to abandon. Instead, the idea is to focus on developing therapeutic agents that can respond to mutant viruses. The company is developing a’cocktail treatment’ that mixes candidate antibody No. 32, which has neutralizing ability against mutant viruses in the UK and South Africa, and Rekirona among the neutralizing antibody platforms it has built.
Celltrion plans to secure additional data on safety and efficacy through Phase 3 clinical trials in about 1,200 mild and moderately ill patients with Corona 19 in more than 10 countries around the world.
A company official said, “We have already completed the production of Rekirona for 100,000 people, and we plan to produce additional 1.5 to 3 million units per year.” I will do my best.”
Reporter Juhyun Lee [email protected]
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