[Asia Economy Reporter Seo So-jeong] The Ministry of Food and Drug Safety (Minister Kim Gang-lip) announced on the 17th that it has approved a change to delete the approval conditions and expand the range of patients eligible for administration after reviewing the global Phase 3 clinical trial report of the COVID-19 antibody treatment 'Rekkirona-ju (Regdanvimab)' submitted by Celltrion on the 10th of last month.
Accordingly, the efficacy and effect of Rekkirona-ju have been changed to approval for 'treatment of mild COVID-19 in high-risk groups and all moderate adult patients,' thereby increasing the number of patients eligible for treatment.
The previous target for mild high-risk groups were mild patients aged 60 or older or those with underlying conditions (one or more of cardiovascular disease, chronic respiratory disease, diabetes, hypertension). With this change, the age criterion was lowered to over 50 years, and the scope of underlying conditions was expanded to include obese patients (BMI over 30), chronic kidney disease patients (including dialysis), chronic liver disease patients, and immunosuppressed patients (such as those undergoing cancer treatment or bone marrow transplantation). The administration method was also shortened from 90 minutes of intravenous infusion to 60 minutes.
According to the Ministry of Food and Drug Safety, the safety of Rekkirona-ju was generally favorable. In the Phase 3 clinical trial, the incidence of adverse events with Rekkirona was similar to that of the placebo group, and most symptoms were mild or moderate. The most frequently reported adverse events were elevated liver enzyme levels and hypertriglyceridemia, and the serious adverse event was an 'infusion-related reaction' (one patient), which recovered within a few days.
The effectiveness of Rekkirona-ju was confirmed to statistically significantly reduce progression to severe disease and the clinical recovery period caused by COVID-19. Among 446 high-risk mild and moderate patients treated with Rekkirona, the rate of progression to severe disease decreased by 72% compared to 434 patients in the placebo group, and the clinical recovery period was shortened by 4.12 days compared to 12.3 days in the placebo group.
The Ministry of Food and Drug Safety sought expert advice and consulted the Central Pharmaceutical Review Committee on whether the Phase 3 clinical trial results of Rekkirona-ju could therapeutically confirm the drug's effectiveness in the patient groups for which Celltrion requested changes. As a result, experts agreed that it is desirable to expand the high-risk group range and apply the drug to mild high-risk and all moderate adult patients based on the Phase 3 clinical trial results.
However, after reviewing all mild cases newly requested as treatment targets by Celltrion in this change approval, it was decided not to include mild cases that are not high-risk in the usage scope due to low incidence of severe progression and insufficient confirmation of effectiveness. Additionally, for 'children aged 12 and over,' since they were not included in the clinical trial subjects, it was deemed appropriate not to include them in the usage scope.
After reviewing the examination results and advisory opinions, the Ministry of Food and Drug Safety comprehensively finalized the usage scope of this drug as ‘mild high-risk and all moderate adult patients’ confirmed in the relevant clinical trial. The Ministry stated, "We expect that this change approval will provide treatment opportunities to more COVID-19 patients," and added, "We will continue to do our best to promptly supply safe and effective treatments to our people."
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