ALK Reports US FDA Approval of Odactra to Treat Children with House Dust Mite Allergy

Shots:

• The US FDA has approved Odactra tablet to treat house dust mite (HDM) induced allergic rhinitis, with or without conjunctivitis, in children (5-11yrs.). Regulatory review in Canada is ongoing
• Approval was based on P-III (MT-12) study assessing Odactra showed significant efficacy & safety in ~1,460 children across North America & EU. Data published in The Lancet Regional Health, Europe
• Additionally, regulatory review for Itulazax (ALK’s tree tablet) for allergic rhinitis in children is ongoing in EU & Canada; expected to complete in 2025

Ref: Globenewswire | Image: ALK

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