FDA approves efficacy supplement for Eli Lilly's Olumiant

The FDA's Drugs@FDA database shows a supplemental approval tied to Eli Lilly and Company's Olumiant (baricitinib), recorded under application number NDA207924. The filing is listed as submission number 10, classified as an efficacy supplement, with approval status marked "AP" and a submission status date of 2026-10-09.¹

The product covered by this application comes in three oral tablet strengths. Olumiant is formulated as an oral tablet containing baricitinib at 1 mg, 2 mg, and 4 mg strengths.¹

Review of the submission was handled under standard timelines rather than priority review. The review priority for this supplement is listed as standard.¹

The FDA's record includes a link to the agency's approval letter for this action. An application document identified as a letter, dated 20261013, is associated with this submission and hosted on the FDA's drug approval documents site.¹

The database entry does not specify which indication, population, or labeling change this efficacy supplement addresses. No further detail on the clinical basis for the supplement, trial data, or new labeling language is included in the available record. Readers seeking the specific nature of this update may need to consult the linked approval letter directly, as the Drugs@FDA listing itself provides only the administrative and regulatory tracking information cited above.

Eli Lilly and Company is listed as the sponsor of the application in the FDA database.