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  • Expanded clinical use of orphan drug 'Joenja' in children
  • by Lee, Hye-Kyung | translator Hong, Ji Yeon | Dec 6, 2024 05:56am
Approval for children aged 4 and older
The Central Pharmaceutical Affairs Advisory Committee (CPAC) seeks consultation on the approval of the clinical trial drug from a foreign country for therapeutic use
Currently available drug is 70 mg formulation, 10 mg and 30 mg tablets will be provided to children
 ¡ã Product photo of Joenja.

The administration¡¤dosage in children for a clinical trial of 'Joenja (leniolisb),' an APDS treatment designated as an orphan drug in South Korea, is expected to be expanded.

The meeting record of the Central Pharmaceutical Affairs Advisory Committee (CPAC), released by the Ministry of Food and Drug Safety (MFDS) on December 4, indicates that there has been a consultation regarding the application for approval of a medication on clinical trial intended for therapeutic use, which is currently undergoing clinical trials in a foreign country.

It was reported that the medication is Joenja, a treatment for activated phosphoinositide 3-kinase delta syndrome (APDS). In June, Joenja was designated as an orphan drug.
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