On the 5th, the Ministry of Food and Drug Safety licensed Celltrion’s new coronavirus infection (Corona 19) antibody treatment’Rekironaju’ (ingredient name Regdanvimab CT-P59). The subject of administration is a mild to moderate adult patient with high risk of COVID-19. On the morning of the 5th, the Ministry of Food and Drug Safety granted permission for the product under the condition of submitting the results of phase 3 clinical trials for Rekkirona at a final inspection committee meeting attended by three outside experts including the Chairman of the Central Pharmacist Review Committee, Yoo-hwan, and five internal members of the Food and Drug Administration, including Kim Kang-rip, Yonhap News
Celltrion’s new coronavirus infection (Corona 19) antibody treatment,’Rekironaju’, is supplied to patients completely free of charge.
Supplied by purchasing collectively with the government budget
3 bottles per person, expected 150,000 won per bottle
Celltrion completes production for 100,000 people
An official from the Korea Centers for Disease Control and Prevention said on the 5th, “Corona 19 treatment has been free from the beginning, and Rekirona will also apply this principle,” he said. “However, the time to start supply has not been decided yet.”
Corona 19 treatment is originally covered by health insurance. 80% of the health insurance is paid, and 20% of the statutory patient contribution is supported by the budget. When Celltrion applies for health insurance to the government, the Ministry of Health and Welfare opens the Health Insurance Policy Review Committee to make a decision. It takes 1-2 months.
The government decided to purchase and supply it in bulk before applying the health insurance. Rekkironaju weight 70kg adult should fit 3 bottles. It is expected to be set at 150,000 won per bottle. The drug costs 450,000 won. It is said that the patient only needs to get 3 bottles once, and there is no need for more.
Celltrion said it has already produced 100,000 medicines and is ready to ship them.
On the afternoon of the afternoon of the 5th, the head of the Ministry of Food and Drug Safety, Kang-rip Kim, announced the results of the final inspection committee for conditional product approval of Celltrion’s novel coronavirus infection (Corona 19) antibody treatment’Recyronaju 960mg (Regdanbimab)’ at the briefing room of the Ministry of Food and Drug Safety in Cheongju, Chungbuk. Is being announced. yunhap news
Kang-rip Kim, head of the Ministry of Food and Drug Safety, said at a briefing on the marketing approval of Rekirona on the 5th, “According to our findings, the production of Rekirona of Celltrion Co., Ltd. is complete. So, if requested at the clinical site, it will be available in the earliest time. I do” he said. Director Kim added, “We understand that the Korean Disease Administration has prepared a plan that can be used first, and we expect to proceed with a specific health insurance application procedure.”
However, the drug is not expected to be supplied right away. An official from the disease administration said, “We are negotiating a drug supply contract with a pharmaceutical company,” and “it seems difficult to supply it at the beginning of next week.”
Reporter Shin Seong-sik [email protected]