Remdesivir has been officially granted over the age of 12

The MFDS approved the change as of the 7th by referring to cases such as the United States

The MFDS has approved the change to use Remdesivir, which was first approved as a treatment for COVID-19, only for those aged 12 or older.

 

However, the EUA was decided for this age group to prevent gaps in pediatric treatment under the age of 12.

 

This is the same as when the U.S.

 

FDA officially approved Remdesivir in October 2020.

 

The MFDS announced on the 7th that it has allowed administration range of Veklury, a treatment for COVID-19, to be changed to "inpatients with severe or pneumonia who are adults and 12 years old and need adjuvant oxygen treatment for children over 40kg." In July 2020, Veklury was conditionally approved to use the results of phase 3 clinical trials on the market for "severe inpatients who need 3.5kg or more of auxiliary oxygen treatment confirmed with COVID-19." As Gilead submitted the results of the global phase 3 clinical trial to implement the permit conditions this time, the results report was reviewed and the scope of administration was allowed to be changed.

 

The MFDS decided to use Veklury for "inpatients with severe or pneumonia who need adjuvant oxygen treatment under the age of 12 or under 40kg (3.5kg or more) considering that there is no COVID-19 treatment available in Korea.

 

Pfizer's oral treatment Paxlovid, which will be introduced soon, is also used only for those aged 12 or older.

 

This measure reflects a comprehensive review of domestic and foreign cases for children and overseas approval cases such as the United States and Japan.

 

When officially approved in October 2020, the United States took the same measures as in Korea, fearing a gap in pediatric treatment.

 

In Japan, it has been used for children since approval.

 

The EUA is a system that allows manufacturers and importers to manufacture and import medicines that have not been licensed in Korea or to supply them with different uses and capacities than those that have already been licensed.