Regulatory Decision Summary for Fucibet
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.
Type of submission:
What was the purpose of this submission?
The purpose of this New Drug Submission is to seek market authorization for Fucibet (fusidic acid and betamethasone valerate) for the topical treatment of eczematous dermatoses in adults and children 6 years and older when secondary bacterial infection caused by Staphylococcus aureus is suspected or confirmed.
Why was the decision issued?
The sponsor, Leo Pharma Inc., has provided adequate efficacy and safety data to support the use of Fucibet in the topical treatment of infected eczema in adults and children 6 years and older. This product has been authorized on the European market with a brand name of Fucicort Lipid Cream for over 10 years under the same conditions of use as those proposed for Fucibet use in Canada.
The primary efficacy data supporting this indication are derived from a Leo study (Study FCF0001) in patients with clinically infected atopic dermatitis, while safety data include both the clinical study data and ongoing European post-market surveillance data.
Study FCF0001 was a randomised double blind, three arm, parallel group, active and vehicle controlled comparative phase III study in patients with atopic dermatitis (AD). In this study the clinical and antibacterial effect of Fucibet was found to be significantly better than that of the Lipid cream vehicle. No significant differences in the incidence of adverse events were found between the Fucibet and the Lipid cream vehicle.
Extensive post-marketing data encompassing over 10 years of clinical use in Europe support the safe use of Fucibet. Based on a pooled analysis of data from clinical studies and spontaneous reporting, pruritis is the most frequently reported adverse reaction during treatment. Additional post-market drug reactions include hypersensitivity and contact dermatitis.
Fucibet is a topical antibiotic/corticosteroid combination treatment for the management of infected eczema. Topical treatments offer a useful alternative to oral agents due to several advantages: they are easy to use, generally they cause fewer side effects than systemic preparations, they result in higher drug concentrations at the eczematous site, and they may be associated with a lower risk for the development of bacterial resistance to the antimicrobial component of the preparation.
Fusidic acid is a narrow-spectrum gram-positive antibacterial that shows negligible systemic absorption and is effective against Staphylococcus aureus (S. aureus), a common commensal and pathogen found in infected eczema. Infection is a consequence of the allergic skin inflammation seen in eczema, but colonisation with S. aureus is also thought to be a cause of the inflammation. Topical fusidic acid has a known and acceptable safety profile. Betamethasone valerate is a potent corticosteroid with an established efficacy and safety profile in the treatment of eczema. The adverse event profile of the combination product, Fucibet is acceptable, comprising mainly application-related and other dermatological adverse events.
Health Canada considers that the benefit/risk profile of Fucibet is favourable in patients aged 6 years and older for the topical treatment of eczematous dermatoses, including atopic eczema, discoid eczema, stasis eczema and seborrheic eczema when secondary bacterial infection caused by Staphylococcus aureus is confirmed or suspected.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.