Summary of Cancellation for RelabotulinumtoxinA (*Relfydence)
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):
RelabotulinumtoxinA
Therapeutic area:
Muscle Relaxants
Type of submission:
New Drug Submission
Control number:
271756
Decision issued:
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
2024-01-16
What was the purpose of this submission?
The purpose of this New Drug Submission (NDS) was to seek market authorization for Relfydence (RelabotulinumtoxinA) for the following indication:
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The temporary improvement in the appearance of:
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Moderate to severe glabellar lines (GLs) associated with corrugator and/or procerus muscle activity, and/or
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Moderate to severe lateral canthal lines (LCLs) associated with orbicularis oculi muscle activity in adult patients.
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What did the company submit to supports its submission?
The sponsor submitted drug quality, and clinical components. The pivotal clinical safety and efficacy information consisted of the following: 3 pivotal Phase III double-blind, placebo-controlled studies (1 with Glabellar Lines (GL) only treatment [43QM1602- READY 1], 1 with Lateral Canthal Lines (LCL) only treatment [43QM1901-READY 2], 1 with treatment in both Glabellar Lines and Lateral Canthal Lines (GL and LCL) regions [43QM1902- READY 3]).
What was the status of the submission when it was cancelled? What was Health Canada’s assessment of the submission at the time of cancellation?
Health Canada’s review of the submission was incomplete at the time of cancellation. During review, Health Canada identified that they were unable to entirely assess the chemistry and manufacturing of the product from the data that was available. Health Canada notified the sponsor of these issues, and the submission was subsequently voluntarily withdrawn.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There is no expected impact for patients using SAP or in clinical trials. For more information about the Special Access Programme refer to the programme’s web site:
https://www.canada.ca/en/health-canada/services/drugs-health-products/special-access.html or https://www.canada.ca/fr/sante-canada/services/medicaments-produits-sante/acces-special.html.
*Proposed Brand Name :
Relfydence
Manufacturer:
Galderma SA
Drug Identification Numbers issued:
N/A
Date filed:
2023-02-09