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.
- APDS is a rare primary immunodeficiency disease caused by genetic mutations in either the PIK3CD or PIK3R1 genes, which leads to hyperactivity of the PI3Kδ (phosphoinositide 3-kinase delta) pathway. Balanced signaling in the PI3Kδ pathway is essential for normal development and function of immune cells in the body. Symptoms of APDS include frequent and severe infections of the ears, sinuses, and upper and lower respiratory tracts, as well as autoimmunity and inflammatory symptoms. People with APDS may also be at higher risk for cancers like lymphoma.
- Joenja is a selective PI3Kδ inhibitor that works to treat APDS by inhibiting the production of phosphatidylinositol-3-4-5-trisphosphate, which is a cellular messenger that regulates a multitude of cell functions.
- Joenja tablets are administered orally, twice daily approximately 12 hours apart, with or without food.
- Warnings and precautions associated with Joenja include embryo-fetal toxicity. Females of reproductive potential are advised to use highly effective contraception.
- Common adverse reactions include headache, sinusitis, and atopic dermatitis.
Development timeline for Joenja
Further information
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