Regulatory Decision Summary for Xeomin Cosmetic
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 submission is the response to the NON for the SNDS for Xeomin Cosmetic (Control # 208713).
The purpose of the original SNDS for Xeomin Cosmetic (NT 201) was to expand the aesthetic indication namely, upper facial lines (UFL) which encompasses the currently authorized indication, glabellar frown lines (GFL) and two new indications, lateral canthal lines (LCL) and horizontal forehead lines (HFL), as well as all combinations thereof (i.e.: GFL + LCL, LCL + HFL, GFL + HFL, GFL + LCL + HFL).
Why was the decision issued?
Based on review of the clinical data in the SNDS, while the efficacy of NT 201 (Xeomin Cosmetic) for the combined treatment of UFL was demonstrated for all three types of UFL in the pivotal clinical study, this increases the total dose of NT 201 from the currently approved dose for GFL by 2.7 to 3.2 fold and increased the rate of NT 201 treatment-related facial paralytic disorders by 4 to 8 fold and the rate of NT 201 treatment-related headache by up to 4 fold. This also resulted in oral pharyngolaryngeal paralytic disorders at a rate of about 0.7% in clinical trials, indicating that the combined treatment of UFL increases the risk of toxin spread to the oral pharyngolaryngeal area. As a result, a NON was issued on July 27, 2018 due to the risk of distant toxin spread outweighing the benefit in the proposed combined treatment of upper facial lines.
In the Response to the NON, the sponsor provided some additional non-clinical and clinical studies related to the potential of distant toxin spread. However these were insufficient to fully address concerns about the risk. Therefore an explicit indication for the combined treatment of UFL is not acceptable and the indication was revised as follows:
"Xeomin Cosmetic is indicated in adults for the temporary improvement in the appearance of moderate to severe horizontal forehead lines, lateral canthal lines, and glabellar lines".
As well, the potential for distant toxin spread in using Xeomin Cosmetic for combined treatment of UFL, as observed in the clinical trials, is to be objectively communicated in the Product Monograph.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations