Regulatory Decision Summary for Alofisel
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:
Summary of Cancellation for Alofisel (Control number 217347)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company cancelled the submission before a final decision was issued.
Date of cancellation
2019-06-05
What was the purpose of this submission?
The purpose of this NDS was to seek Canadian market approval of darvadstrocel for treatment of complex perianal fistula(s) in adult patients with non-active or mildly active luminal Crohns disease.
What did the company submit to support its submission?
Takeda Canada Inc. submitted clinical, quality, and labelling components.
What was the status of the submission when it was cancelled? What was Health Canadas assessment of the submission at the time of cancellation?
Health Canadas review of the submission identified deficiencies with the data provided to support the proposed indication for darvadstrocel. These deficiencies were not resolved at the time of cancellation. The sponsor chose to voluntarily withdraw their submission without prejudice to refiling.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
There are no consequences to patients accessing the drug under SAP or any ongoing or proposed clinical trials.
Additional information
N/A
*Proposed Brand Name
ALOFISEL