FDA approves efficacy-related supplement for Eli Lilly's Verzenio
The agency approved supplement 21 for the abemaciclib tablet, an efficacy-type submission, with the approval dated July 13, 2026.
The U.S. Food and Drug Administration approved supplement 21 to the New Drug Application for VERZENIO (abemaciclib), a submission classified as Efficacy that was filed under submission status AP with a submission status date of 2026-07-131.
VERZENIO is sponsored by Eli Lilly and Co and is available as an oral tablet in four strengths: 50MG, 100MG, 150MG, and 200MG, each containing abemaciclib as the active ingredient1.
The submission was reviewed under standard review priority, as indicated by the review_priority field marked STANDARD1.
Two application documents accompanied the approval. A labeling document was issued with a date of 20260715, and an approval letter was issued with a date of 202607201.
The FDA's record identifies this as an efficacy-type supplemental submission, but the underlying documents made available do not specify whether the approval introduces a new indication, updates dosing or administration language tied to existing indications, or otherwise revises efficacy-related labeling. Readers seeking the exact nature of the change should consult the newly posted label, dated July 15, 2026, and the approval letter, dated July 20, 2026, both linked in the FDA's Drugs@FDA database for application number 208716.
No additional details on trial data, patient population, or specific label changes were included in the source record for this submission.
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.