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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 a meeting of the verification advisory group of the Ministry of Food and Drug Safety, the effect on the improvement of clinical symptoms in mild to moderate adult patients was recognized, and opinions on approval were collected under the condition of a Phase 3 clinical trial.
On the 18th, Kim Sang-bong, head of the Biopharmaceutical Office of the Ministry of Food and Drug Safety, explained the product approval status of ‘Recyronaju’, and revealed the results of the ‘Safety Verification Advisory Group and Effectiveness of Corona Treatment / Vaccines 19 ‘(hereinafter, verification advisory group).
The verification advisory group is a procedure for the Ministry of Food and Drug Safety to gather advisory opinions in areas such as clinical, non-clinical and quality from various experts before 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 attended, including the general review team of the ‘Corona 19 Treatment Approval Review Team’ within the Ministry of Food and Drug Safety, and a clinical review team.
Director Kim Sang-bong said: “At the verification counseling meeting held on the 17th, we were informed whether the results of the clinical trial of ‘Rekironaju’ were appropriate to recognize the therapeutic effect of this drug, its safety, etc. ” “We analyzed whether the results of the indicators to measure clinical efficacy and the indicators to measure the working principle of the drug used in the trial are appropriate to recognize the therapeutic effect of this drug.”
The Celltrion clinical trial of “ Recyronaju ” was carried out by administering this medicine or placebo in patients who developed any of the seven corona symptoms19 (fever, cough, shortness of breath, sore throat, systemic pain, fatigue and headache). The intensity of all symptoms appearing up to 14 days (twice a day) was observed and the time elapsed (recovery period) until all seven symptoms were considered to disappear or weaken was measured.
As a result, the recovery period was 5.34 days in the Rekirona injection group (40 mg / kg) and 8.77 days in the placebo group, indicating a reduction in the recovery period of approximately 3.43 days.
Director Kim Sang-bong said: “The verification advisory group decided that the reduction in time to improvement of Corona 19 symptoms by administering ‘Recyronaju’ was statistically significant and clinically significant.”
Furthermore, Celltrion measured the transition time 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. There was no significant difference over 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 the administration of Rekirona,” he said. “We gather opinions that the results on the time required for negative virus transduction are of no clinical importance.”
On the other hand, the verification advisory group determined that the results of this clinical trial do not reveal the effect of Rekirona in reducing patients requiring hospitalization or oxygen therapy.
Director Kim said: “The verification advisory group showed a trend to decrease the proportion of patients requiring hospitalization or oxygen therapy due to Corona 19 in the group administered with Rekirona, but this item is a complementary method to confirm the effectiveness and statistically by separated in the planning stage of the clinical trial. He said: “It is an opinion that it is difficult to draw a definitive conclusion at this time because the test method has not been determined,” he emphasized. “Therefore, it has been concluded that it is necessary judge specific results and meanings through a phase 3 clinical trial that will be conducted in 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 proportion between the two groups and there were no serious, life-threatening cases.”
Director Kim said: “The verification advisory group has proposed a product authorization with the premise of conducting a phase 3 clinical trial for ‘Recyronaju’ combining the above views.” Added, “he said.
The efficacy and effect of ‘Recicronaju’ 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 (older than 18 years).
Verification advisory group ▲ Celltrion will confirm that it significantly reduces mild-moderate to severe morbidity for a sufficient number of patients in phase 3 clinical trial ▲ Regarding use in clinical field, separate discussions with relevant organizations for specific guidance Establish one line ▲ Conditional approval is recommended for patients requiring 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 Pharmaceutical Safety is the legal advisory body to the Ministry of Food and Pharmaceutical Safety by reviewing submitted data, including expert opinions, efficacy effects (drafts), and recommendations obtained through this advisory group. verification, and some of the quality data that remains. The central pharmacy review committee plans to receive advice on safety, efficacy, and issues to consider when allowing the application article, “he explained about the future procedure.
