The FDA database lists a supplement, dated 25 September, to the new drug application for baricitinib (Olumiant). The listing does not say what the supplement covers. Supplements can concern labelling, manufacturing or, less often, a new use; without detail, no clinical change can be assumed.
For prescribers, nothing changes today. Baricitinib is a JAK inhibitor, and the existing precautions for the class, covering infection, thrombosis, cardiovascular risk and malignancy in higher-risk patients, continue to apply. Its CDSCO status is not affected by an FDA supplement.
- No change to baricitinib prescribing follows from this listing.
- Continue to assess infection, thrombosis and cardiovascular risk before starting a JAK inhibitor.
- Screen for tuberculosis and hepatitis B before starting.
- Watch for published detail if the supplement turns out to change the label.
Why it matters
A listing without detail is not a label change, and should not be read as one.
Don't overread it
A licence supplement is not a new indication.
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