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pp-166

Tablets 70 mg

Dossier type
CTD
Dossier status
Ready to file
Country of origin
European Union
GMP approvals
FDA, EU GMP
Comments
Indication: Activated PI3Kδ syndrome (APDS) type 1 (PIK3CD gain-of-function) and type 2 (PIK3R1 loss-of-function) — adults and paediatric patients ≥12 years Clinical stage: FDA approved 2023; EMA approved 2024; expansion studies in younger children ongoing Modality: Small molecule Mechanism / Target: Selective PI3Kδ inhibitor — blocks constitutive PI3Kδ activity in B and T lymphocytes; corrects lymphocyte differentiation defects, reduces lymphoproliferation and recurrent infections Route / form: Oral tablet (70 mg twice daily) Differentiation: First approved PI3Kδ inhibitor for APDS; addresses root molecular cause; superior specificity vs idelalisib (which also inhibits PI3Kα/β); approved in rare primary immunodeficiency
Manufacturer #39191

Rare disease biopharmaceutical company with approved recombinant protein and small-molecule therapies. Develops targeted treatments for primary immunodeficiencies and rare inflammatory disorders. Wholly owned commercialised and pipeline assets with global development strategy.
 

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