Celltrion COVID-19 Treatment Set for European Entry...Preliminary Review Process Underway

EMA Begins 'Rolling Review'

Celltrion COVID-19 Antibody Treatment Regkirona (Photo by Celltrion)

[Asia Economy Reporter Kim Ji-hee] Celltrion announced on the 25th that the European Medicines Agency (EMA) has initiated a 'rolling review' of the COVID-19 antibody treatment Regkirona. This marks the official start of the review process for Regkirona's marketing authorization in Europe.

EMA's rolling review is a system used by the Committee for Medicinal Products for Human Use (CHMP) under EMA to accelerate the evaluation of treatments or vaccines during crisis situations such as pandemics. Before the final approval application, data and documents regarding the drug's efficacy, safety, and quality are submitted by the company in real-time and are promptly prioritized for review.

To expedite Regkirona's global approval, Celltrion has already submitted quality and manufacturing process management data, as well as non-clinical and clinical trial data, to the EMA. Based on the data submitted by Celltrion, CHMP will begin evaluating Regkirona's efficacy and safety.

After completing the global Phase 2 clinical trial of Regkirona, Celltrion has been conducting preliminary consultations with major regulatory agencies worldwide, including the European EMA and the U.S. Food and Drug Administration (FDA), to proceed with expedited approval procedures. Following the completion of the global expedited approval process, Celltrion is also ensuring smooth supply by securing production volumes without delay. Production for 100,000 doses has already been completed, and depending on demand, an additional 1.5 million to 3 million doses of Regkirona are planned for annual production.

Furthermore, efforts are being accelerated to establish a variant response platform to address mutant viruses. Simultaneously, development has begun on a cocktail therapy combining Regkirona with candidate antibody No. 32, which has shown neutralizing ability against the UK and South African variants. Celltrion is conducting Phase 3 clinical trials involving approximately 1,200 mild to moderate COVID-19 patients across more than 10 countries worldwide. This aims to further secure data on Regkirona's safety and efficacy across a broader patient population.

A Celltrion official stated, "With the initiation of EMA's rolling review, the approval process for supply to Europe has officially begun. Since preliminary consultations are also underway with major countries worldwide, we will diligently submit all requested data and documents by regulatory agencies to ensure the early supply of Regkirona to help end the global pandemic."

This content was produced with the assistance of AI translation services.