On 2 September 2026 the FDA's Drugs@FDA database recorded a supplement to new drug application 213871, Pfizer's abrocitinib (Cibinqo), an oral JAK1 inhibitor licensed in the US for refractory moderate-to-severe atopic dermatitis.
The record does not say what the supplement changed. Supplements cover labelling, manufacturing and other changes, and only some involve new indications or safety information. Until the updated label is published, nothing here changes how abrocitinib should be used.
The existing boxed warning for JAK inhibitors on serious infection, malignancy, major cardiovascular events and thrombosis still applies.
- No change to abrocitinib prescribing follows from this notice alone.
- Continue screening for tuberculosis and hepatitis before starting a JAK inhibitor.
- Check lipids and blood counts as the existing label advises.
- Weigh cardiovascular and thrombotic risk before prescribing to patients over 65 or with risk factors.
Why it matters
A supplement can precede a label change, so it is worth watching for the updated prescribing information.
Don't overread it
A licence supplement is not a new indication or a new safety warning.
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