Celltrion’s novel coronavirus infection (Corona 19) antibody treatment drug’Recyronaju (ingredient name regdanvimab, development name CT-P59)’ received conditional approval under the condition of conducting a phase 3 clinical trial.
As a result of the meeting of the Ministry of Food and Drug Safety verification advisory group, the effect was recognized in improving clinical symptoms in mild to moderate adult patients, and opinions were gathered on approval under the condition of a phase 3 clinical trial.
On the 18th, Kim Sang-bong, head of the Bio-Pharmaceutical Bureau of the Ministry of Food and Drug Safety, explained the status of the item approval of’Recyronaju’ and revealed the results of the’Corona 19 Treatment/Vaccine Safety and Effectiveness Verification Advisory Group’ (hereinafter referred to as verification advisory group).
The verification advisory group is a procedure for the Ministry of Food and Drug Safety to collect advisory opinions on areas such as clinical, non-clinical, and quality from various experts prior to consulting the Central Pharmacy Review Committee.The verification advisory group meeting is an infectious medicine specialist, virology expert, and clinical statistics expert. Eight external experts in the field of clinical trials, including the general review team of the’Corona 19 treatment approval review team’ inside the Ministry of Food and Drug Safety, and 4 people including the clinical review team attended.
Director Kim Sang-bong said, “At the verification advisory meeting held on the 17th, we were advised on whether the results of the clinical trial of’Rekironaju’ were appropriate for acknowledging the therapeutic effect of this drug and safety, etc.. “We looked at whether the results of the indicators for measuring the clinical effectiveness and the indicators for measuring the principle of operation of the drug were appropriate to acknowledge the therapeutic effect of this drug.”
Celltrion’s clinical trial of’Rekirona’ was administered to patients who developed any of the 7 symptoms of Corona 19 (fever, cough, difficulty breathing, sore throat, body pain, fatigue, and headache). The intensity of all symptoms appearing up to 14 days was observed (twice daily), and the time taken (recovery period) until all seven symptoms were judged to disappear or weaken was measured.
As a result, it was confirmed that the recovery period was 5.34 days in the Rekirona injection group (40mg/kg) and 8.77 days in the placebo group, indicating a reduction in the recovery period of about 3.43 days.
Director Kim Sang-bong said, “The verification advisory group decided that the reduction in the time for improvement of Corona 19 symptoms by administering’Recyronaju’ was statistically significant and clinically significant.”
In addition, Celltrion measured the time to transition from positive to negative as a result of the virus test by collecting nasopharyngeal samples from the Rekirona injection group and the placebo group, and compared the two groups. It was confirmed that there was no significant difference in time.
Director Kim said, “The verification advisory group is not statistically significant, but it is an opinion that a tendency to decrease the concentration of virus in the body was observed after administration of Rekirona,” he said. “We gathered opinions that the results on the time required for negative transduction of the virus have no clinical significance.”
On the other hand, the verification advisory group determined that the results of this clinical trial do not reveal the effect of Rekirona on the reduction of patients requiring hospitalization or oxygen therapy.
Director Kim said, “The verification advisory group showed a tendency to decrease the proportion of patients who need hospitalization or oxygen therapy due to Corona 19 in the Rekirona-administered group, but this item is a supplementary method for confirming the effectiveness, and statistically separately at the stage of clinical trial planning. He said, “It is an opinion that it is difficult to draw a definite conclusion at the moment because the test method has not been determined,” he emphasized. “Therefore, it has been concluded that it is necessary to judge specific results and meanings through a phase 3 clinical trial that will be conducted on many patients in the future.”
Regarding the safety of’Rekironaju’, Director Kim said, “The hypertriglyceridemia and hypercalcemia that occurred after receiving this drug were predictable adverse events already confirmed in the phase 1 clinical trial.” “There were cases of abnormalities, but there was a similar ratio between the two groups, and there were no serious cases of life-threatening.”
Director Kim said, “The verification advisory group has proposed a product authorization on the premise of conducting a phase 3 clinical trial for’Recyronaju’ by combining the above views.” I added,” he said.
The efficacy and effect of’Recyronaju’ recommended by the verification advisory group is ▲ mild-moderate, such as those who do not need supplemental oxygen supply ▲ who developed symptoms within 7 days before administration, etc. It is the improvement of clinical symptoms in adult patients with COVID-19 (over 18 years of age).
The verification advisory group ▲Celltrion will confirm that it significantly reduces mild-moderate to severe morbidity for a sufficient number of patients in the phase 3 clinical trial ▲Concerning clinical field use, separate discussions with relevant organizations for specific guidance Establish a line ▲ Conditional approval is recommended for patients who need supplemental oxygen therapy, subject to separate clinical trials in combination with this drug and existing severe treatments or other immunomodulators.
The Ministry of Food and Drug Safety is the Ministry of Food and Drug Safety’s legal advisory body by reviewing the submitted data, including expert opinions, efficacy effects (drafts) and recommendations obtained through this verification advisory group, and some of the quality data still remaining. The central pharmacy review committee is planning to receive advice on the safety, effectiveness, and matters to be considered when permitting the application item,” he explained about the future procedure.