Regulatory Decision Summary for Itulatek

The purpose of this submission is to extend the indication of the tree Sublingual Immunotherapy tablet (SLIT) to include the paediatric population (5-17 years). Additionally, the purpose of this submission is to include oak pollen among the indicated tree species.

A large international study was conducted to see if a new treatment called Itulatek could help children and teenagers (ages 5-17) suffering from moderate to severe allergic rhinitis (runny, blocked, or itchy nose) and conjunctivitis (red, watery, or itchy eyes) caused by birch pollen. The study took place in several European countries, Canada, and Russia over two years.

Who Participated and How the Study Was Run

• Participants: The trial enrolled nearly 1,000 children and teens who not only reacted to birch pollen but many were also allergic to other common allergens such as grass, pet dander (cats and dogs), and dust mites.

• Design: The study was randomized and double-blind, meaning neither the participants nor the researchers knew who was receiving Itulatek or a placebo (a treatment with no active ingredient).

• Data Collection: Participants recorded their daily symptoms and any use of allergy medications in an electronic diary. This information was combined into a “total combined score” (TCS), which reflected both symptom severity and medication use.

What the Study Measured

• Primary Goal: The main measurement was the average TCS during the peak birch pollen season.

• Secondary Goals: Other scores looked separately at daily symptoms and medication use throughout both the peak birch season and the longer overall pollen season (which included alder, hazel, and oak pollen as well).

Key Findings on Effectiveness

• Overall, Itulatek led to about a 20% improvement in the combined symptom and medication score compared to placebo during the peak pollen season.

• The benefits were most noticeable in younger children (ages 5–11), who showed a 26% improvement, while the improvement in teenagers was minimal.

Safety and Side Effects

• General Safety: Itulatek was mostly safe, and side effects were generally mild to moderate.

• In Children: Some experienced more frequent abdominal pain, nausea, or mouth irritation than typically seen in adults, and a small number developed or experienced worsening oral allergy syndrome.

• In Adolescents: Aside from a slight increase in throat irritation and rash compared to adults, one teenager had a serious allergic reaction (anaphylaxis) after the first dose.

• Risk Management: To manage these risks, physicians and caregivers were advised about the potential for severe allergic reactions, and the availability of epinephrine autoinjectors was recommended, along with additional safety monitoring after the drug’s approval.

Conclusion

The trial’s overall assessment was that the benefits of Itulatek outweigh its risks for treating birch pollen-related allergic symptoms in children and adolescents, supporting its use for this condition.

An updated Risk Management Plan (RMP) for Itulatek was reviewed by Health Canada and considered acceptable.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

For further details about Itulatek, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.