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Joenja FDA Approval History

Last updated by Judith Stewart, BPharm on March 28, 2023.

FDA Approved: Yes (First approved March 24, 2023)
Brand name: Joenja
Generic name: leniolisib
Dosage form: Tablets
Company: Pharming Group N.V.
Treatment for: Activated PI3K-Delta Syndrome

Joenja (leniolisib) is a kinase inhibitor indicated for the treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.


Development timeline for Joenja

Mar 26, 2023Approval FDA Approves Joenja (leniolisib) for the Treatment of Activated Phosphoinositide 3-Kinase Delta Syndrome (APDS)
Sep 28, 2022Pharming Announces US FDA Acceptance for Priority Review of its New Drug Application for Leniolisib

Further information

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