Minister of Food and Drug Safety Kim Kang-rip is speaking at the final inspection committee for COVID-19 treatment held at the Food and Drug Administration in Osong-eup, Cheongju-si, Chungbuk on the 5th. News 1
Celltrion Co., Ltd.’s new coronavirus infection (Corona 19) antibody treatment,’Rekkironaju’ (ingredient name Regdanvimab CT-P59) received conditional approval from the Ministry of Food and Drug Safety on the 5th. It is the first treatment in Korea.
The Ministry of Food and Drug Safety’s Final Inspection Committee, held on that day, decided to approve the product under the condition of submitting the results of the phase 3 clinical trial. The final inspection committee is the last of the three-stage expert consultation process. In the future, Rekironaju is expected to be used in patients with moderate corona19 and high-risk mild patients over 60.
Celltrion antibody treatment. yunhap news
Conditions for submitting phase 3 clinical results
According to the Ministry of Food and Drug Safety, the final inspection committee decided to license the conditional item on the premise of submitting the results of phase 3 after the sale of Rekkirona. Eight members attended the final inspection committee, including Yu-hwan, chairman of the Biological Medicines Subcommittee of the Central Pharmacist Review Committee and Kim Kang-rip, head of the Food and Drug Administration. In general, it is necessary to complete phase 3 clinical trials to obtain approval for a new drug. However, as the Corona 19 epidemic continues, the procedure has been reduced. The deadline for permit review, which took more than 180 days, has also been extended to 39 days.
Rekironaju was advised that it is effective in improving the clinical symptoms of patients with moderate corona19 disease over the age of 18 who have pneumonia symptoms. It is also permitted to be used in high-risk patients with mild symptoms of one or more of cardiovascular disease, chronic respiratory system disease, diabetes, and hypertension. The Ministry of Food and Drug Safety explained that it was to prevent worsening of symptoms. In clinical trials, the result was a 54% reduction in the incidence of severe patients. Rekironaju also showed that the symptom improvement period decreased by 3.43 days.
The time required for’Eumjeon’ in Rekkirona
However, as a result of the virus test, there was no significant difference in the time between positive and negative conversion (the time required for virus negative conversion) between the patients who received the drug and those who did not. The effect on the mortality rate is also unknown.
However, no serious side effects occurred. The dosage and administration were determined to be intravenous injection of 40mg of Rekirona per 1kg of adult body weight for 90 minutes (±15 minutes).
At the Celltrion 2 plant in Yeonsu-gu, Incheon, a researcher is looking at CT-P59, a COVID-19 antibody treatment. News 1
The mutant virus effect is
Rekironaju is an antibody treatment. It is made by using the neutralizing antibody gene in the blood of a cure for Corona 19. Mass production is possible by recombining genes. It was the first domestically developed drug to be approved. It is the third in the world after multinational pharmaceutical companies Eli Lilly and Regeneron therapy.
It has not been confirmed to what extent it is effective against the’mutant virus’ that is popular around the world. Celltrion and the Korea Centers for Disease Control and Prevention are conducting tests in this regard.
Will it be a game changer
Among experts, it is predicted that antibody treatments are difficult to become a’game changer’ for Corona 19.
Kim Woo-joo, a professor of infectious medicine at Korea University’s Guro Hospital, said, “An antibody treatment approved for emergency use was distributed to the US medical field, but only 20% of the secured quantity was used. You have to look carefully.”
In a recent discussion, the head of the Central Infectious Diseases Hospital Operation Center of the National Medical Center said, “The neutralizing antibody that responded to the existing virus through mutation may not play its role.” “Rather, it is ambiguously combined with the mutant virus to help cell penetration and proliferation. There is” he said.
At a briefing on the day, the head of the Food and Drug Administration, Kim Kang-rip, said, “We have not yet obtained objective research results on the mutant virus.” However, six (Corona 19) gene types that were prevalent in Korea were verified. If meaningful research results are submitted according to domestic and foreign research results, we will make necessary judgments accordingly.”
Reporter Minwook Kim [email protected]