MFDS Begins Review of Celltrion's COVID-19 Antibody Treatment

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety (MFDS) announced on the 11th that it has begun data review and on-site investigations for Celltrion's novel coronavirus disease (COVID-19) antibody treatment, 'Rekkironaju' (Rekkironaju).

The MFDS stated, "We have received a total of three clinical trial result data conducted domestically and internationally on Rekkironaju, along with other review materials, and are currently reviewing them focusing on the validity of the clinical trial results."

Among the clinical trial result data, two were Phase 1 trials conducted on 32 healthy individuals and 18 patients with mild COVID-19, respectively. The MFDS is reviewing data that confirmed the safety of the initial dose administered to humans.

The remaining data is from a Phase 2 trial conducted on 327 patients with mild to moderate COVID-19 to demonstrate safety and efficacy.

This Phase 2 clinical trial added indicators to evaluate effects such as clinical symptom improvement, in addition to general evaluation indicators like shortened virus reduction time. Also, the proportion of patients requiring hospitalization or oxygen therapy, which is confirmed in Phase 3 clinical trials, was set as a supplementary confirmation item.

The MFDS collected nasopharyngeal specimens from individuals administered with the drug to verify whether the drug's mechanism?where the virus binds to the drug instead of human cells, thereby inhibiting infection?actually occurs in the body. They conducted virus tests, measured the time taken for conversion from positive to negative, and compared the shortened time between patients who received the drug and those who did not.

Additionally, the MFDS critically evaluated how quickly patients administered with the drug recovered from seven COVID-19 symptoms: fever, cough, dyspnea, sore throat, myalgia (muscle pain), fatigue, and headache, to assess clinical effectiveness. The incidence rate of patients requiring oxygen supply, mechanical ventilation, or hospitalization was also evaluated as an additional measure.

The MFDS said, "The Phase 2 clinical trial designed as above is similar in form and purpose to a Phase 3 clinical trial. If therapeutic effects are confirmed in Phase 2, we may consider product approval on the condition that Phase 3 clinical trial results are submitted."

Last week, the MFDS conducted on-site inspections at two Celltrion manufacturing sites. Since Rekkironaju is a sterile injectable drug, the manufacturing area must have facilities and environments necessary to prevent contamination by fine particles and microorganisms and maintain specified cleanliness levels.

This week, to verify compliance with regulations throughout the clinical trial, including the safety of clinical trial subjects and the reliability of trial results, on-site investigations will be conducted at clinical trial institutions (medical institutions). Early next week, a review meeting of the 'COVID-19 Vaccine and Therapeutics Safety and Efficacy Verification Advisory Group,' which includes external experts, will be held.

[Image source=Yonhap News]

Additionally, the MFDS has begun formal review of the submitted data after preliminary review of the COVID-19 vaccine approval application submitted by Korea AstraZeneca. The vaccination target for 'AstraZeneca COVID-19 Vaccine Injection' is individuals aged 18 and over, with the dosage regimen applied for approval being a single dose (0.5 ml) followed by a second dose (0.5 ml) 4 to 12 weeks later.

The MFDS stated, "While reviewing the product's efficacy, we are also closely examining adverse events occurring during non-clinical and clinical trials. In particular, the efficacy and safety in elderly individuals aged 65 and over will be analyzed separately."

The MFDS plans to conduct an on-site inspection of the manufacturing site (SK Bioscience) for manufacturing and quality control evaluation within this month.

The MFDS said, "We will continue to thoroughly verify the safety and efficacy of COVID-19 therapeutics and vaccines under development and do our best to review applications as quickly as possible."

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