Regulatory Decision Summary for Acarizax
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Contact:
Medicinal Ingredient(s):
Standardized allergen extract, house dust mites (D. farinae and D. Pteronyssinus)
Control Number:
285056
Brand/Product Name:
Acarizax
Therapeutic Area:
Allergens
Type of Submission:
Supplement to a New Drug Submission
Decision Issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
Acarizax is a house-dust mite (HDM) sublingual immunotherapy (SLIT) tablet that has been developed for sublingual immunotherapy of allergic rhinitis (AR) and/or conjunctivitis induced by HDM and has been approved in Canada since 2017 for ages 12 years and older.
The purpose of the current submission is to extend approval of the HDM SLIT-tablet Acarizax for the treatment of children (5-11 years) with HDM AR or HDM AR with or without conjunctivitis in accordance with the approved label.
Why was the decision issued?
The efficacy of Acarizax in treating pediatric patients aged 5-11 with house dust mite-induced allergic rhinitis/rhinoconjunctivitis was evaluated in a randomized, double-blind, placebo-controlled trial (MT-12). The trial involved 1,460 subjects who received either Acarizax or placebo for 12 months. The primary endpoint, the total combined rhinitis score (TCRS), showed a significant improvement in the Acarizax group compared to placebo, with a 22% relative difference. The treatment effect varied among patients depending on their allergic disease status.
Regarding safety, data from three clinical trials (MT-03, MT-11, and MT-12) involving 895 children revealed that Acarizax was generally well tolerated. The most common treatment-related adverse reactions were local, such as abdominal pain, lip swelling, and nausea, with higher incidences in pediatric patients compared to adults. No anaphylactic reactions were reported. The safety profile for children with asthma was similar to those without asthma, and there were no serious safety concerns overall.
An updated Risk Management Plan (RMP) for Acarizax was reviewed by Health Canada and considered acceptable.
Risk mitigation activities included labelling of potential risks and additional parental supervision requirements when administering Acarizax to children aged 5 to 11 years.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
Overall, the benefit-harm-uncertainty profile was favourable for Acarizax 12 SQ-HDM/tablet for the approved indication when used under the conditions of use recommended in the approved Product Monograph. Therefore, a Notice of Compliance (NOC) was recommended.
For further details about Acarizax, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2025-03-05
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription Status:
Available by prescription only
Date Filed:
2024-03-18
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ACARIZAX | 02463644 | ALK-ABELLÓ A/S | DERMATOPHAGOIDES FARINAE 6 UNIT DERMATOPHAGOIDES PTERONYSSINUS 6 UNIT |