FDA approves efficacy supplement for Eli Lilly's Olumiant (baricitinib)
The FDA cleared a ninth supplemental application for Olumiant under a standard review, with the approval recorded on September 25, 2026.
The U.S. Food and Drug Administration approved a supplemental application for Olumiant, the oral tablet form of baricitinib made by Eli Lilly and Co., according to FDA records. The submission is listed as SUPPL 9 for NDA207924, classified as an efficacy submission, and its status was updated to approved with a submission status date of 2026-09-25.1
The FDA record shows the review carried standard priority rather than priority review. Olumiant is approved in three oral tablet strengths of baricitinib: 1mg, 2mg, and 4mg.1
The FDA's public database entry does not specify what change or new indication the efficacy supplement covers, nor does it include details on clinical trial data, dosing changes, or labeling updates that may accompany this approval. Readers seeking the specific nature of this ninth supplemental efficacy submission would need to consult the full FDA approval letter or Eli Lilly's own disclosures, as the drugs@FDA database record provided here contains only the administrative status of the submission.
No additional milestones, trial results, or company statements were included in the available FDA filing data for this update.
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