Summarized by Masters of Longevity from FDA - Drugs.
A news article describing an approval decision that expands a targeted oral therapy to younger children with a rare immune disorder, and what readers should expect from the report.
Key Takeaways
- The FDA approved leniolisib tablets for children aged 4–11 years weighing at least 27 kg.
- Leniolisib was previously approved in 2023 for patients aged 12 and older at 70 mg orally twice daily.
- This approval designates leniolisib as the first indicated treatment for activated PI3Kδ syndrome in this pediatric age group.
