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# Odactra Approved for Expanded Use
- URL: https://www.fdaweb.com/odactra-approved-for-expanded-use/
- Published: 2025-02-28T12:00:00.000Z
- Updated: 2026-09-14T14:54:18.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5158744

FDA has approved an ALK supplemental BLA for Odactra (house dust mite allergen tablet) to expand its use for treating house dust mite-induced allergic rhinitis, with or without conjunctivitis, to now include children ages five through 11 years. Previously, the product was approved for use in patients aged 12 through 65 years.

Approval was based on data from a Phase 3 clinical trial in 1,458 children ages five through 11 years old. In the study, children treated with Odactra showed a “relative reduction” in a rhinitis score of 22% versus placebo, the company says. “The safety profile in the study was consistent with the established safety profile for adults and adolescents,” it adds.