ALK-Abello Secures Latest ODACTRA Label Update as CBER Iterative Review Record Spans Eight Years

ALK-Abello's ODACTRA approval history now stretches across seven discrete CBER actions dating from March 2017 through February 2025, making it one of the more documented iterative labeling records for a sublingual allergen extract in the biologics register. For regulatory affairs leads at allergen extract manufacturers, the cumulative file offers a working template for managing post-approval supplement cycles under 21 CFR Part 601.

ODACTRA (House Dust Mite Dermatophagoides farinae and Dermatophagoides pteronyssinus Allergen Extract, STN 125592) is indicated for immunotherapy in HDM-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive IgE in vitro testing or licensed skin-test reactivity. The approved population spans persons 5 through 65 years of age. Manufacturer of record is ALK-Abello A/S, Horsholm, Denmark.

The approval sequence, March 2017, February 2020, September 2020, January 2023, December 2023, and twice in February 2025, reflects the kind of rolling supplement activity that QA directors and regulatory leads should anticipate across a biologic's commercial lifecycle. Each action generated its own Clinical Review Memo and Statistical Review, building a layered evidentiary record that CBER reviewers can reference against demographic subgroup data cited in Section 1.1 of the most recent Clinical Review Memo.

For allergen extract manufacturers operating under biologics license, the ODACTRA file illustrates how labeling obligations evolve well beyond initial approval. Demographic subgroup analyses, medication guide revisions, and package insert updates each carry their own submission and review timelines, requiring sustained coordination between regulatory affairs, pharmacovigilance, and CMC teams. The February 27, 2025 approval letter is the most current controlling document on record.

The February 2025 action brings the total documented supplement cycle to at least six post-original approvals, a volume that underscores the resource planning implications for manufacturers maintaining active BLAs in the allergenics category.

Source: FDA CBER / What's New: Vaccines, Blood & Biologics RSS Feed, June 10, 2026.