“Celltrion corona treatment, recommended for use only in moderate and high risk groups other than mild”… Ministry of Food and Drug Safety Phase 2 Consultation Results (General)
Celltrion (068270)In the second phase of consultation of the Ministry of Food and Drug Safety,’Rekkironaju’ (ingredient name’regdanvimab’), an antibody treatment for novel coronavirus infection (Corona 19) of It is recommended that it is evaluated. It was found that “it is difficult to draw a conclusion” about the appropriateness of administration to general mild patients.
The Ministry of Food and Drug Safety held an advisory meeting of the’Central Pharmacist Review Committee (Central Medicines Deliberation Committee)’, a legal advisory body at 2 pm on the 27th, and evaluated the efficacy and safety of Rekkirona, and announced the results at 7 pm.
The Chinese Medicines and Drug Administration said, “As the necessity is recognized, we will be able to approve the product subject to the submission of the results of the phase 3 clinical trial.” “There is no such thing as a symptom of a patient who developed symptoms within 7 days prior to administration of the drug.”
Conditions for patients receiving Rekirona as recommended by the Central and Drug Administration. / Provided by the Food and Drug Administration
For patients with mild symptoms, “We could not confirm a statistically significant treatment effect because we could not secure enough patients in the 2nd phase of the clinical trial. We can verify (definite treatment effect) through more accurate clinical design for more patients. I said. Accordingly, there is a possibility that mild patients, which account for the majority of COVID-19 patients, will be excluded from the treatment of Rekirona, which will be possible as early as next month.
However, it could be used for patients with high risk (elderly, patients with underlying diseases, etc.) who are at high risk of developing severe even among mild patients, according to the judgment of the medical staff.
Regarding safety, he recommended that “no serious life-threatening events have occurred, but a phase 3 trial and post-marketing continuous evaluation will be necessary for a sufficient number of patients.”
Drug conditional authorization procedure. / Provided by the Food and Drug Administration
According to the consultation on the day, if only the final inspection committee, which is the last three-stage advisory body, goes through safely, it is expected that approval will be granted early next month and can be used for some patients. Earlier, on the 29th of last month, the Ministry of Food and Drug Safety announced that it would decide whether or not to grant the conditional approval of Rekirona State, which Celltrion applied for, within 40 days after consulting three experts.
On the 18th, the’Verification Advisory Group’, a first-stage advisory body, evaluated that “Rekironaju reduces the symptom improvement period of patients by 3.43 days,” and “the result is statistically significant and clinically significant.” On the 13th, Celltrion said, “The recovery period of the treatment group was 5.4 days, which was 3.4 days shorter than the placebo group (8.8 days).”
Lee Dong-hee, director of the Korea Food and Drug Administration, was in charge of announcing the results of consultation with the Ministry of Food and Drug Safety on the 27th. / Provided by the Food and Drug Administration
Celltrion has completed production of 100,000 people at its Songdo production facility in Incheon since September last year so that it can be marketed as soon as the conditional permit is approved, and plans to produce an additional 3 million people within the year. Applications for emergency use approval (EUA) in the US and Europe are also being prepared.
Conditional approval is a system that the Ministry of Food and Drug Safety permits to be marketed first with only the results of phase 2, subject to phase 3 progress and completion.
Rekirona is an injection containing antibodies with antiviral efficacy as the main component, and is administered intravenously at a dose of 960 mg for about 90 minutes. When administered to mild and moderate corona19 patients, it is expected to have the effect of killing the virus and preventing severe progression.
