Input 2021.02.05 14:00 | Revision 2021.02.05 16:00
“Even if you want to use general mild patients, in principle not”
Concerns about being’powerless in mutation’ “There is no reason to judge yet”
First domestic developer… World’s third among antibody treatments
The Ministry of Food and Drug Safety announced on the 5th that “a final inspection committee composed of experts has been held, and it has been decided to permit the use of Rekkirona under the condition of submitting the results of phase 3 clinical trials within this year.”
The Ministry of Food and Drug Safety said, “The efficacy and effectiveness of this drug is to improve clinical symptoms in moderate and high-risk patients with mild symptoms,” he said. “We have confirmed these patients as targets for use.” The’moderate patient’ is a corona19 patient who suffers from weaker pneumonia rather than severe, and the’high risk group’ is a mild patient over 60 years old, or a mild patient with one of vascular disease, chronic respiratory disease, diabetes, and hypertension as an underlying disease. It was defined as.
The Ministry of Food and Drug Safety said, “Generally mild patients excluding high-risk patients cannot use it in principle even if they want to use it,” he said. “However, there is room for use if it is deemed necessary according to the clinical judgment of the medical staff.”
The use of drugs on 1,172 patients currently in the recruitment phase has become virtually difficult until the efficacy of all mild patients has been demonstrated through a Phase III trial.
Celltrion’s efficacy for mild patients, which account for the majority of patients with mild and moderate symptoms, initially targeted for treatment was not recognized. The company has revealed that the effect of preventing severe development is expected if Rekirona is administered to mild patients in the early stages of infection.
On the 27th of last month, the Central Pharmacist Review Committee, the 2nd expert advisory group of the Ministry of Food and Drug Safety, said, “We could not confirm the statistically significant treatment effect because we could not secure enough (mild) patients in the second phase of clinical trial.” “We will be able to verify (definite efficacy) through accurate clinical design.” The Ministry of Food and Drug Safety incorporated this recommendation into its decision.
Antibody treatments, including Rekirona, are feared that they may be powerless against mutant viruses from Britain, South Africa, and Brazil, or may have an adverse effect on helping the virus grow. In this regard, the Ministry of Food and Drug Safety said, “The final inspection committee discussed the efficacy and the possibility of side effects, but we have not yet secured a scientific basis for clear judgment.” The efficacy of Leckirona against the mutant virus will be announced before the Lunar New Year holidays.
The Ministry of Food and Drug Safety said, “We will conduct thorough monitoring of side effects in the use process and cooperate with relevant ministries so that patients can use it safely.” I will do it.”
On December 29, last year, Celltrion submitted the results of the phase 2 clinical trial to the Ministry of Food and Drug Safety and applied for permission to use Rekkirona in Korean medical fields. The Ministry of Food and Drug Safety made this decision after going through a total of three expert advisory meetings, 39 days after the application date. A total of eight people attended the advisory meeting, including three outside experts, including the Chairman of the Biological Medicines Subcommittee of the Central Pharmacy Review Committee, and five from the Ministry of Food and Drug Safety, including Kim Kang-rip, the head of the Food and Drug Administration.
Rekyronaju is an antibody treatment that mainly contains neutralizing antibodies that bind to the Corona 19 virus and reduce infectivity and toxicity. It became the third officially licensed antibody treatment in the world after the treatments of Eli Lilly and Regeneron in the United States. It is administered by intravenous injection for about 90 minutes, and a single dose is 40 mg per 1 kg of patient’s body weight. Celltrion has produced 100,000 servings to supply to the medical field immediately after approval.