Celltrion’s new coronavirus infection (Corona 19) antibody treatment Rekyronaju (ingredient name regdanvimab, development name CT-P59) received approval for therapeutic use on the 29th of last month.
This is the third approval for use for treatment purposes of Rekirona, and the first approval for use for treatment purposes after the announcement of the results of Rekkirona’s Global Phase 2 at the 2021 High1 New Drug Development Symposium on January 13th.
The approval for use for therapeutic purposes is a system in which pharmaceuticals undergoing clinical trials are used with approval from the Ministry of Food and Drug Safety for the treatment of emergency patients who are in danger of life or have no alternative treatment means. When medical staff apply for drug use, the Ministry of Food and Drug Safety reviews and approves it. However, it can be administered only to individual patients with permission. The medical institution that applied for this treatment purpose approval is Seoul Asan Hospital.
Celltrion announced the results of Phase 2, and in terms of the incidence of mild and moderately severe patients requiring hospitalization treatment, 54% of all patients were compared with placebo based on the established dose of Rekirona (40 mg/kg). It was reported that there was a 68% decrease in the group of patients with moderate illness over the age of 50.
In addition, it was explained that the time until clinical recovery was shortened by more than 3 days when taking Rekyrona injection to 5.4 days in the Rekyrona-treated group and 8.8 days in the placebo-treated group.
In particular, he emphasized that the time taken to show clinical recovery when taking Rekirona injection in patients with moderate or severe symptoms over 50 years of age was shortened by 5-6 days or more compared to the placebo group.
At the time of the announcement of the phase 2 results, Joong-Sik Um, a professor of infectious medicine at Gachon University Gil Hospital, who was in charge of the clinical researcher (PI), said, “Rekkironaju can open a new chapter in high-risk treatment by preventing the occurrence of severe corona19 patients and shortening the treatment period. Expect it. It is expected that it will play a large role in the management of medical resources because it can reduce the burden on medical institutions and give considerable room for treatment.”
Currently, the conditional permit for Phase III of Rekkirona has crossed the arm ridge.
The Ministry of Food and Drug Safety announced the results of the verification advisory group meeting on the 18th of last month and recognized the effect of improving the clinical symptoms of Rekirona for mild and moderate adult patients.On the 29th of the same month, the Central Pharmacy Review Committee recommended conditional approval of Rekirona. .
However, the Central Pharmaceutical Affairs Committee evaluated the clinical significance of Rekirona injection for mild patients and recommended it for use in a limited group of patients including moderate and high risk patients with mild symptoms.
On the other hand, Celltrion is waiting for the conditional approval of Rekkirona State from the Ministry of Food and Drug Safety, past January as expected.
An official from Celltrion said, “We are currently waiting for conditional approval from the Ministry of Food and Drug Safety.” “There are no other changes.”