[Press Release, Jan 27, 2021 / unofficial translation ]


Meeting Results of the Central Pharmaceutical Advisory Committee for COVID-19 Therapeutics



□ The Ministry of Food and Drug Safety (MFDS, Minister Kim Ganglip) clarifies the marketing approval progress for the COVID-19 therapeutics, Regkirona Inj., as follows.


1. Central Pharmaceutical Advisory Committee Meeting
□ On January 27 (Wednesday), the Ministry of Food and Drug Safety held a Central Pharmaceutical Advisory Committee (CPAC) meeting to get advice on the safety and clinical efficacy of Celltrion’s antibody treatment, Regkirona Inj.
○ A total of 18 external experts attended the Central Pharmaceutical Advisory Committee meeting, including 12 standing members of the Biopharmaceutical Subcommittee, a specialized subcommittee for the safety and clinical efficacy evaluation of biopharmaceuticals, 5 experts from the Advisory Committee*, and 1 expert recommended by the Korean Medical Association, as well as 6 officers from the Overall Evaluation Team, Clinical Evaluation Team, and Quality Evaluation Team of the ‘COVID-19 Emergency Response Support’ in the MFDS.
* COVID-19 Vaccine Safety and Efficacy Advisory Committee
○ To secure expertise and objectivity in the COVID-19 therapeutics approval process, the MFDS collects a broad range of opinions from authoritative experts in various fields.
- The MFDS adopts a procedure to seek advice by operating the Central Pharmaceutical Advisory Committee in accordance with Article 18 of the Pharmaceutical Affairs Act on matters related to the safety and clinical efficacy of new drugs.
- Considering the severe COVID-19 pandemic situation, the MFDS has additionally organized the Advisory Committee for the Safety and Efficacy Assessment of COVID-19 Vaccine/Therapeutics and the Final Evaluation Committee to get a 3-Tiered advisory process.


2. Advice from the CPAC
□ During the Central Pharmaceutical Advisory Committee meeting, several pieces of advice were given on whether it is appropriate to recognize the safety and clinical efficacy of Regkirona Inj. on the condition that the Phase III clinical trial results be submitted after marketing authorization.
○ In particular, based on the safety and efficacy review results of Regkirona Inj., various expert opinions were expressed on the necessity of its domestic use and matters to be considered when approving the Regkirona Inj. as a COVID-19 therapeutic.


3. Advice Results of th CPAC
□ In careful consideration of the results of reviewing the safety and clinical efficacy of Regkirona Inj. 960 mg (regdanvimab) based on data submitted by Celltrion for approval, as well as patients’ accessibility to COVID-19 therapeutics and right of choice of medical staff,
○ The CPAC advised that Regkirona Inj.’s necessity among domestic patients is recognized. As such, its marketing approval can be granted if the Phase III clinical trial results are submitted after marketing authorization.
○ However, unlike the previous Advisory Committee’s opinion, the CPAC recommended that it is difficult to conclude the clinical significance of Regkirona administration to patients with mild symptoms and recommended to use Regkirona Inj. for a limited group of patients.
- Therefore, the CPAC suggested the administration of Regkirona Inj. to patients with moderate illnesses and high-risk patients with mild symptoms.
○ Based on data submitted by Celltrion regarding safety after administration of Regkirona Inj., no life-threatening severe adverse events occurred. However, the CPAC advised that it is vital to conduct a Phase III clinical trial for a sufficient number of patients and ensure continuous safety evaluation after marketing authorization.
○ However, several committee members suggested, as a minority opinion, to utilize a specific manufacturing approval system rather than marketing approval.

< Recommendations of the Central Pharmaceutical Advisory Committee >
Improving the clinical symptoms in outpatients with mild to moderate SARS-CoV-2 infection (ages 18 and over) who meet the following criteria:
1) Those whose oxygen saturation exceeds 94% in indoor air
2) Those who do not require supplemental oxygen therapy
3) Those who had symptoms within seven days before drug administration


4. Future Plan for Therapeutics Approval and Evaluation
○ The MFDS will continue evaluating Regkirona Inj. after receiving additional evaluation data, such as some quality data* from Celltrion.
* Some safety data and data on raw material management of raw material medicines
- The Ministry will finally decide whether to approve Regkirona Inj. throughout the Final Evaluation Committee by synthesizing expert opinions, efficacy and effectiveness, and recommendations obtained from the Avdvisory Committee and the CPAC.

□ The MFDS will collect various expert opinions in the approval and evaluation process for COVID-19 therapeutics or vaccines to secure objectivity and transparency and exert its utmost efforts to ensure a scientific approval and evaluation process.