Celltrion has applied for approval of COVID-19 treatment

Phase II clinical trial end, the MFDS, targets within 40 days

Celltrion applied for accelerated approval of an antibody treatment COVID-19, the MFDS initiated a review.

 

Celltrion announced on the 29th that it has applied to the MFDS for accelerated approval of CT-P59 (Regdanvimab), COVID-19 antibody treatment.

 

An application for authorization was filed based on the recently ended global phase II clinical trial.

 

Celltrion

Based on the clinical results, Celltrion is also starting a procedure for obtaining EUA in the US and Europe.

 

This global clinical phase II was designed through prior consultation with the MFDS the US Food and Drug Administration (FDA), and the European Medicines Agency (EMA).

 

A total of 327 patients from South Korea, Romania, Spain and the United States participated and completed the final medication on November 25th.

 

Celltrion explained, “We have completed the analysis of the detailed data of this clinical trial through domestic and foreign experts and self-evaluation, and have immediately submitted an application for approval because we have determined that we have secured sufficient grounds for applying for accelerated approval from the Ministry of Food and Drug Safety for CT-P59.

 

The MFDS requested that detailed clinical data related to the safety and efficacy of CT-P59 be not disclosed until there is a separate guideline, in view of the recent focus of the public on COVID-19 treatment.

 

Celltrion plans to present the results of this phase II clinical trial in detail at an international conference soon.

 

In addition, based on the results, it plans to quickly enter phase III clinical trials in 10 countries around the world to further verify the safety and efficacy of CT-P59 through a broader patient group.

 

Celltrion is also promoting the overseas Emergency Use Authorization (EUA) procedure of CT-P59.

 

While sharing the data on the results of this phase II clinical trial in detail with the FDA and EMA, consultations on the submission of applications for approval will be initiated, and They will be submitted to most of these countries in January of next year.

 

When responding to inquiries about orders from overseas government agencies, it plans to induce pre-orders while explaining the results of this phase II clinical trial in detail so that domestic supply is possible as soon as possible as soon as EUA is available.

 

An official from Celltrion said, “We are grateful to domestic and foreign health authorities, medical institutions, and participating patients who have actively supported this clinical trial to be completed smoothly as planned.

 

Special thanks are also to the dozens of our employees who have been dedicated to working in the US and Europe.” The MFDS has initiated the CT-P59 permit review process.

 

The MFDS explained, "As Celltrion submitted the application for permission and related data, the approval review began." The submitted data is preliminary reviewed by the high-tech product licensing officer, and then a pre-configured “COVID-19 Vaccine/Therapeutic License Review Team” examines the data necessary for approval, such as non-clinical, clinical, and quality.

 

After that, the review opinions are synthesized to determine the validity of the permit, and the final approval is obtained after consulting the Central Pharmaceutical Affairs Review Committee composed of external experts.

 

The MFDS aims to shorten the existing processing period (180 days or more) and process it within 40 days for the rapid approval and review of COVID-19 vaccine and treatment, including the product for this approval.

 

An official from the MFDS explained, "We will thoroughly verify the safety and effectiveness by using experts in each field and external experts of COVID-19 Vaccine and Treatment License Examination Team so that safe and effective COVID-19 treatment can be used by the public."