MFDS "Celltrion COVID-19 Antibody Treatment Advisory Panel Meeting on the 17th"

[Image source=Yonhap News]

[Asia Economy Reporter Cho Hyun-ui] The Ministry of Food and Drug Safety (MFDS) will hold an advisory committee meeting on the clinical trial data of Celltrion's novel coronavirus disease (COVID-19) antibody treatment, 'Rekkironaju,' on the 17th.

According to the MFDS on the 14th, the advisory committee meeting will seek advice on whether the clinical results regarding the clinical efficacy measurement indicators used in the Rekkironaju clinical trials and the drug's mechanism of action measurement indicators are appropriate to recognize the therapeutic effect of this drug.

The clinical efficacy measurement indicators evaluate how quickly patients who received the treatment recover from seven COVID-19 symptoms: fever, cough, difficulty breathing, sore throat, systemic pain (muscle pain), fatigue, and headache. The drug's mechanism of action measurement indicators assess how much the time is shortened for the virus test results to convert from positive to negative.

The results will be disclosed on the following day of the meeting, the 18th.

The MFDS stated, "In the approval review process of COVID-19 treatments and vaccines, we will gather diverse expert opinions to ensure objectivity and transparency, and conduct thorough approval and review."

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