ALK Reports Health Canada’s Approval of Itulatek to Treat Children and Adolescents with Allergic Rhinitis
Shots:
- Health Canada has approved Itulatek (tree pollen sublingual tablet) to treat mod. to sev. seasonal allergic rhinitis &/or conjunctivitis, induced by pollen from birch, alder, hazel, &/or oak in pts (5-17yrs.); applications under the Swissmedic & MHRA’s review, with decision expected this year
- Approval was based on P-III (TT-06) trial assessing Itulatek vs PBO in above pts (n=952), showing favorable safety; data was published in the European Journal of Allergy and Clinical Immunology
- Itulatek, branded as Itulazax in EU, is approved in 22 countries for adults (18–65yrs.) & was recently approved for children & adolescents (5–17yrs.) in 17 EU states
Ref: Globenewswire | Image: ALK
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