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Joenja (leniolisib) for Activated PI3K delta syndrome (APDS), children 4 to 11

Pharming · sNDA
Approved
The FDA approved this application. Approval is the starting line, not the finish: our guide to what happens in the 90 days after a rare disease approval walks through specialty pharmacies, insurance review, and how families shorten the wait.

What the FDA decided

The FDA approved Pharming's sNDA for Joenja (leniolisib) in Activated PI3K delta syndrome (APDS), children 4 to 11. Approved September 11, 2026 as the first treatment for APDS in children aged 4 to 11 who weigh at least 27 kg (about 60 pounds), with weight-based dosing. Joenja was first approved in 2023 for ages 12 and up. The FDA based the pediatric approval on safety and drug-level data from a single-arm, open-label study in which 8 children received the recommended weight-based dose.

Frequently asked questions

Has the FDA decided on Joenja?

The FDA has already decided. It approved the application.

Details: the outcome and what it means are at the top of this page.

Source: FDA approval notice

What was Joenja approved for?

The FDA approved Pharming's sNDA for Joenja in Activated PI3K delta syndrome (APDS), children 4 to 11.

What to know: Approved September 11, 2026 as the first treatment for APDS in children aged 4 to 11 who weigh at least 27 kg (about 60 pounds), with weight-based dosing. Joenja was first approved in 2023 for ages 12 and up. The FDA based the pediatric approval on safety and drug-level data from a single-arm, open-label study in which 8 children received the recommended weight-based dose.

How much will Joenja cost?

Trial Friend does not list a price for Joenja. What you pay depends on your insurance and on help from the drugmaker or a charity fund.

Find help: the patient assistance finder lists programs by insurance type.

What happens after the Joenja decision?

The FDA approved Joenja for Activated PI3K delta syndrome (APDS), children 4 to 11 on September 11, 2026.

Next steps: getting the drug still takes time. Specialty pharmacy setup, insurance review and patient assistance often take weeks. Our guide covers what families can do on day 1.

Where this date comes from

The FDA does not publish PDUFA dates; companies disclose them. This one comes from FDA approval notice. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified daily.