Conditional approval on Celltrion COVID-19 treatment advised

Recommended to alleviate mild to moderate symptoms, but demanded a sufficient number of participants in Phase III

The South Korean health authority’s panel of experts verified the clinical results and advised an approval of Celltrion’s COVID-19 monoclonal antibody treatment candidate Rekirona with a condition to conduct Phase III trial.

 

The panel recommended the drug to be used to alleviate the mild to moderate COVID-19 symptoms in adult patients.

 

The Ministry of Food and Drug Safety (MFDS) stated a meeting for the advisory panel to verify the safety and efficacy in COVID-19 treatment and vaccine candidate was convened on Jan.

 

17 to discuss about the clinical results of Celltrion’s antibody treatment Rekirona.

 

Prior to the consultation with the Central Pharmaceutical Affairs Deliberation Committee, the advisory panel was gathered to provide advice on clinical and non-clinical drugs and quality.

 

The panel meeting consisted of eight external experts including infectious disease specialist, virologist, clinical statistic expert and other clinical trial experts, and four members from the Review Team and Clinical Trial Evaluation Team under MFDS COVID-19 Treatment Approval Evaluation Team.

 

The advisory panel provided their assessment on the Rekirona injection’s clinical trial outcome to confirm the treatment’s efficacy and safety.

 

The clinical efficacy was evaluated by how fast a patient recovers from seven COVID-19 symptoms (fever, coughing, shortness of breath, sore throat, muscle ache, fatigue and headache) after receiving the candidate treatment.

 

The pharmaceutical mechanism was evaluated by timing how fast a patient’s viral test result change from positive to negative.

 

Advisory panel “Shortened symptom alleviation time clinically meaningful" The trial participants either took the drug or a placebo twice-daily, when they expressed any one of the COVID-19 symptoms at a high or medium level.

 

The researchers measured the time to alleviate or weaken all of their symptoms, after monitoring them until Day 14.

 

As a result, the patients administered with the investigational drug took 5.34 days to recover from the COVID-19 symptoms, when the patients administered with a placebo took 8.77 days.

 

The drug was confirmed to reduce the time to alleviate the COVID-19 symptoms by approximately 3.43 days.

 

The panel judged the clinical outcome is meaningful as it statistically proved the drug could lessen the time to improve the COVID-19 symptoms.

 

The trial also tested the participants who have received the treatment for the change in the viral load to verify the mechanism of preventing the viral infection in a human body by letting the drug to bind with the novel virus instead of a human body cell.

 

The virus test confirmed there is no significant difference between the drug-administered group and the control group with the duration of time the test result change from positive to negative.

 

Although the shortened duration was not statistically meaningful, the panel claimed the administration of the drug seemed to show a tendency to decrease the viral load.

 

Recommends conditional approval, but needs sufficient Phase III evidence To confirm the safety of the drug, the researchers monitored the administered participants until Day 28 to observe adverse reaction and any internal infusion related reaction for its frequency, type and severity.

 

In the end, the type of adverse reactions like hypertriglyceridemia and hypercalcemia were predictable as they were reported from Phase I trial already.

 

The majority of the cases were mild or moderate, and the rate was similar to that of the control group.

 

None of life-threatening case was reported.

 

Overall, the advisory panel recommended approving Rekirona, with a condition to conduct a Phase III trial, but also they laid down a few advices on the product’s efficacy and effect; the treatment clinically demonstrated alleviating mild to moderate COVID-19 symptoms in adult patients aged 18 and over, who does not require supplementary oxygenation, but showed the symptoms within seven days of the injection.

 

The advisory panel demanded the South Korean company to conduct a Phase III to verify meaningful decrease in the disease progression from mild-to-moderate to severe in sufficient number of patients, and to set a detailed guideline for the use in the clinical scene by discussing it with the government separately.

 

Also, the panel advised the company to conduct another trial to verify the combination of the treatment candidate and other severe symptom treatment or an immunomodulator to be used on patients who needs supplementary oxygenation.

 

MFDS plans to utilize the panel’s advices, recommended efficacy and effect and indication and outstanding evidence material to review the investigation drug, and to seek for advices on safety, efficacy and pre-approval consideration from the Central Pharmaceutical Affairs Deliberation Committee, a legal advisory panel under MFDS.