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According to the related industry on the 31st, Celltrion started recruiting and administering patients for phase 3 clinical trials. The number of subjects in the phase 3 clinical trial was 1,172, a significant increase of more than 3.5 times that of 327 in the second phase. The drug will be administered without limiting mild, moderate, or severe symptoms in people who have been onset for about 5 days. Phase 3 clinical trials will be conducted not only in Korea, but also in 10 countries including the United States, Spain, Romania and Italy. “We have already started phase 3 clinical trials,” said Sang-jun Lee, senior vice president in charge of clinical trials in Rekirona. I think this will happen quickly.”
Earlier, the Ministry of Food and Drug Safety’s advisory body, the Verification Advisory Group and the Central Pharmacy Review Committee, concluded that the Ministry of Food and Drug Safety may approve the product subject to the submission of the results of phase 3 clinical trials. However, the verification advisory group explained that it was difficult to draw a definite conclusion on whether the transition from mild to moderate to severe in phase 2 was significantly reduced, and that the effect on the mortality rate was not known. The Central Pharmacopoeia recommended that the treatment group should be limited to high-risk patients with mild and moderate symptoms because it is difficult to draw conclusions about the clinical implications for mild patients in phase 2. At the same time, he said that phase 3 clinical trials should be conducted with enough patients.
Celltrion plans to focus on whether the rate of transition from mild to moderate patients to severe decreases and mortality rates through phase 3 clinical trials. The policy is to resolve the recommendations raised during the approval process by recruiting a sufficient number of patients. Vice President Lee said, “(Hospitalization rate, mortality rate, etc.) in the second phase of clinical trials, all the parts that were said to be significant because there are few patients will be resolved.”
Celltrion Rekironaju remains only the gateway to the final inspection committee until conditional approval. The final inspection committee is planning to decide whether or not to approve the approval by synthesizing the opinions of the verification advisory group and the central pharmacy. Approval is expected as both the verification advisory group and the Zhongyang Pharmaceutical Center have concluded that they recommend conditional permits. The permit is expected to be issued in early February.
Celltrion, Celltrion, has already completed production of Rekirona products that can be administered to 100,000 people. It plans to produce an additional 2.5 million to 3 million people in Rekkirona within this year.