Celltrion "COVID-19 Antibody Treatment 'Rekkirona' Approved for Use in Europe" (Comprehensive)

European Medicines Agency Issues Recommendation for Use Before Marketing Authorization

[Asia Economy Reporter Seo So-jung] Celltrion announced on the 26th (local time) that the European Medicines Agency (EMA) has issued an opinion recommending the use of the COVID-19 antibody treatment 'Rekkirona' before its formal marketing authorization. As a result, European countries can now use Rekkirona based on EMA's usage recommendation prior to formal approval.

Since early March, EMA has initiated a review process to provide expert opinions so that individual European national health authorities, urgently needing COVID-19 treatments before EMA marketing authorization, can decide on the introduction of Rekkirona through programs such as the 'Compassionate Use Program.'

Accordingly, the expert group under EMA's Committee for Medicinal Products for Human Use (CHMP) reviewed the quality, non-clinical, and clinical data of Rekkirona submitted by Celltrion. They concluded that administering Rekkirona to high-risk COVID-19 patients likely to progress to hospitalization can reduce the rate of severe disease progression and hospitalization, leading to this decision.

Celltrion is conducting prior consultations with individual European countries to ensure the rapid global supply of Rekkirona and expects that global supply will accelerate based on this outcome.

Celltrion is also in discussions with the U.S. Food and Drug Administration (FDA) and major regulatory agencies of the Organisation for Economic Co-operation and Development (OECD) for the approval of Rekkirona.

Celltrion to produce an additional 1.5 to 3 million doses annually... "Responding to global demand"

Celltrion completed the production of 100,000 doses of the treatment last year and plans to produce an additional 1.5 to 3 million doses of Rekkirona annually to promptly respond to global demand.

Separately from the country-specific usage recommendations, EMA has also been conducting a 'Rolling Review' procedure for pre-authorization evaluation since the 24th (local time).

To expedite the marketing authorization of Rekkirona, Celltrion submitted quality and manufacturing process control data, non-clinical test data, and clinical trial data required for the rolling review to EMA. Based on the various data submitted by Celltrion, CHMP is evaluating the efficacy and safety of Rekkirona.

Meanwhile, at this CHMP meeting, it was also recommended to approve a variation application for RemsimaSC to allow direct administration without prior dosing of the intravenous (IV) formulation for the rheumatoid arthritis (RA) indication. Until now, RemsimaSC administration was only possible after at least two doses of the IV formulation.

A Celltrion official stated, "Following EMA's usage recommendation, we will smoothly conduct prior consultations with individual countries so that European COVID-19 patients can benefit from Rekkirona at an early stage," adding, "If RemsimaSC can be administered directly without prior IV dosing, it is expected to greatly improve the convenience of administration for patients in Europe."

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