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Canadian Drug Review Reimbursement Decision

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Generic Azelaic acid
Company Bayer Inc.
Indication rosacea
Condition Skin and subcutaneous tissue
Submission Type
Patient Population Azelaic acid has a Health Canada indication for the treatment of inflammatory papules and pustules and erythema of mild-to-moderate rosacea. Azelaic acid has antikeratinizing and antibacterial properties, but its mechanism of action in rosacea is unknown. It is available as a 15% topical gel, and the Health Canada-approved dose is 0.5 g applied twice daily.
Status Complete
Date of Recommendation 2011-02-16
Recommendation Summary List
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that azelaic acid 15% gel be listed.
Reason for Recommendation In two randomized controlled trials (RCT) azelaic acid 15% gel had similar efficacy compared with metronidazole, as either 0.75% or 1% gel, for patients with mild-to-moderate papulopustular rosacea in terms of reduced lesion count and investigator assessed global severity. Of Note: Azelaic acid 15% gel is similar in cost to metronidazole 0.75% gel, but more costly than metronidazole 1% gel, when all three products are applied at the frequencies recommended in the product monographs.
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.

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