South Korea conditionally approves first domestic COVID-19 treatment
Topics: SOUTH KOREA
The Ministry of Food and Drug Safety said in a statement that it granted a marketing authorization for Regkirona Inj. 960mg (regdanvimab) on condition of submitting the results of a global phase-three clinical trial.
Celltrion made the application to the agency on Dec. 29, and announced the results in January from a global phase-two clinical study.
Regkirona Inj. is a recombinant neutralizing antibody drug, produced by selecting a neutralizing antibody gene in a COVID-19 convalescent patient's blood and inserting the selected gene into a host cell that is cultured for the large-scale production of the antibody.
The treatment candidate can be administered to COVID-19 outpatients with mild symptoms at high risk, which refer to people aged over 60 years or with more than one underlying disease among cardiovascular risk, diabetes, high blood pressure and chronic respiratory disease, as well as outpatients with moderate symptoms aged 18 or higher.
It can be administered by intravenous infusion that is directly injected into the vein for about 90 minutes.
The drug safety agency said Regkirona Inj. was the first approved COVID-19 treatment as a domestically-developed drug and the third regulatory-verified COVID-19 antibody treatment in the world.
It added that the use of the drug along with other vaccines can help combat the COVID-19 pandemic. ■