The Food and Drug Administration (FDA) has expanded the approval of Odactra® to include treatment of house dust mite (HDM)-induced allergic rhinitis in patients 12 to 17 years of age.

Odactra is an allergen extract indicated as immunotherapy for the treatment of HDM-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. The first dose of Odactra is administered in a health care setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. If the first dose is tolerated, subsequent doses may be taken at home.

The approval for use in adolescent patients was based on data from an open-label, single-arm, 28-day phase 3 trial (ClinicalTrials.gov Identifier: NCT04541004) that evaluated the safety of Odactra in patients 12 to 17 years of age (N=253) with HDM allergic rhinitis. Overall, the safety profile in adolescents was found to be consistent with that observed in adults.

Additionally, a post hoc analysis of the pooled adolescent subpopulation from 2 double-blind, placebo-controlled trials showed that treatment with Odactra appeared to be effective, reducing the average total combined rhinitis score (primary endpoint) by 22% compared with placebo (treatment difference, -1.04; P <.01).

In adolescent patients, the most common adverse reactions reported were throat

irritation/tickle, itching in the mouth, itching in the ear, tongue pain, stomach pain, swelling of the uvula/back of the mouth, swelling of the lips, swelling of the tongue, throat swelling, nausea, tongue ulcer/sore on the tongue, and mouth ulcer/sore in the mouth, and diarrhea.

“We are proud to now offer Odactra, a convenient allergy immunotherapy tablet that can be taken at home following an initial administration visit with a health care provider experienced in diagnosing and treating allergies, to adolescents in the United States,” said Hans Lindeberg, senior vice president of ALK North America. “Odactra is a flexible solution that offers the opportunity for relief as teens and parents navigate their overscheduled lives.”

Odactra is supplied as a sublingual tablet that dissolves within 10 seconds.

References

  1. US FDA approves ALK’s Odactra® (house dust mite allergen extract) tablet for sublingual use as immunotherapy for adolescents. News release. January 25, 2023. https://www.prnewswire.com/news-releases/us-fda-approves-alks-odactra-house-dust-mite-allergen-extract-tablet-for-sublingual-use-as-immunotherapy-for-adolescents-301729972.html.
  2. Matsuoka T, Bernstein DI, et al. Pooled efficacy and safety data for house dust mite sublingual immunotherapy tablets in adolescents. Pediatric Allergy and Immunology. Published online June 29, 2017. doi:10.1111/pai.12747
  3. Odactra. Package insert. ALK-Abelló A/S; 2023. Accessed January 25, 2023. https://www.odactra.com/assets/pdf/odactra-full-pi.pdf.