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.
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What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for ACARIZAX as treatment for house dust mite (HDM)-induced asthma in adults 18 years of age and older, and for HDM-induced allergic rhinitis (AR), with or without conjunctivitis, in adolescents and adults 12 years of age and older, when confirmed (for both these indications) by a positive skin prick test and/or in vitro testing for D. farinae or D. pteronyssinus IgE antibodies. Upon review, ACARIZAX was approved for the treatment of moderate to severe HDM-induced AR (confirmed by testing), with or without conjunctivitis, in adults 18 to 65 years of age.
Why was the decision issued?
The Biologics and Genetic Therapies Directorate (BGTD) considered that the asthma indication for ACARIZAX could not be granted, given that no other allergy immunotherapy tablet (AIT) product marketed in Canada has been authorized for this indication, and given that ACARIZAX is contraindicated in severe asthma.
ACARIZAX will allow patients with house dust mite-induced allergic rhinitis, a chronic debilitating condition affecting a substantial portion of the Canadian population, to self-treat at home after a first dose has been taken under medical supervision.
The efficacy of ACARIZAX for the treatment of HDM-induced AR in subjects 18 to 65 years of age was established in two pivotal double-blind, placebo-controlled, randomized field efficacy trials (Studies P001 and MT-06) which showed significant clinical and statistical improvement in the Total Combined Rhinitis Score. A supportive double-blind, placebo-controlled, randomized environmental exposure chamber trial (P003) showed significant clinical and statistical improvement in the Total Nasal Symptom Score.
ACARIZAX can cause life-threatening local and systemic allergic reactions, including anaphylaxis. Most reactions occur minutes after the first dose, but have also occurred with subsequent doses. Asthma exacerbations may also occur.
Efficacy and safety have not been well established in subjects < 18 and > 65 years of age.
A Risk Management Plan was submitted and reviewed by the Marketed Health Products Directorate (MHPD). As specified in labelling, key provisions were that a definitive diagnosis of HDM-induced AR must first be established, and that the first dose of ACARIZAX be given under medical supervision.
The overall benefit/risk profile for treatment of HDM-induced AR with ACARIZAX is favourable.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ACARIZAX | 02463644 | ALK-ABELLO A/S | DERMATOPHAGOIDES FARINAE 6 UNIT DERMATOPHAGOIDES PTERONYSSINUS 6 UNIT |