Government “Approved as a condition for submitting phase 3 results in case of confirmation of treatment effect”
The government “is also devising a plan to administer it to patients with high age and high risk”
Food and Drug Administration likely to approve celltrion drug product approval early next month
Phase 2 clinical trial of GC Green Cross·Chong Kun Dang treatment ends… Apply for permission soon
As the results of clinical trials for the domestic COVID-19 treatment have been announced one after another, expectations for the emergence of native treatments are increasing.
It may not be optimistic, but the government is expecting to get out of the tunnel of Corona 19 through the introduction of vaccines and domestic treatments.
Reporter Lee Dong-woo reports
Celltrion is the first pharmaceutical company to disclose the results of clinical trials for COVID-19 treatment.
Celltrion’s Rekironaju announced that it has significantly reduced the incidence of severe patients as well as the time it takes to recover as a result of conducting a phase 2 clinical trial for mild and moderate Corona19 patients.
The government is in the position that if the treatment effect is confirmed as a result of the review, the product will be approved under the condition of submitting the results of phase 3 clinical trials.
If necessary, a plan is also being devised to administer it to patients with high age and high risk.
[장희창 / 국립감염병연구소장 : 국립감염병연구소는 식약처 승인 전이라도 의료인이 필요하다고 판단하는 경우 고연령·고위험 환자들에게 치료제를 투여하는 방안에 대해서 식약처와 협의 후 대한감염학회를 통해 연구자 임상시험 수요를 조사했습니다.]
Inside and outside the industry, it is expected that product approvals from the Ministry of Food and Drug Safety will be issued by the beginning of next month at the latest.
However, experts point out that the effectiveness of the treatment is still unclear.
[이혁민 / 세브란스 진단검사 의학과 교수 : 그런데 지금 현재 평가된 데이터는 임상 2상 데이터입니다. 임상 2상 데이터기 때문에 저희가 치료 효과를 완전하게 알기 어려운 부분들이 꽤 있거든요.]
Following Celltrion, GC Green Cross and Chong Kun Dang are also planning to complete phase 2 clinical trials of treatments for severely ill patients with COVID-19 and apply for conditional approval from the Ministry of Food and Drug Safety sooner or later.
Daewoong Pharmaceutical is also developing a treatment for patients with mild and severe corona19, and with meaningful results, it is a position to apply for emergency use approval.
In addition, Bukwang Pharm, Shinpoong Pharm, and Dong Wha Pharm are conducting phase 2 clinical trials to develop COVID-19 treatment.
This is YTN Lee Dong-woo.
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