Summary of Cancellation for Elidel
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:
Medicinal ingredient(s):
Pimecrolimus
Therapeutic area:
Topical calcineurin inhibitor
Type of submission:
Supplement to a New Drug Submission
Control number:
247851
Decision issued:
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
2023-09-14
What was the purpose of this submission?
Elidel (pimecrolimus) Cream 1% is authorized as a second-line therapy for short term and intermittent long-term therapy of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 3 months of age and older, in whom the use of alternative, conventional therapies is deemed inadvisable because of potential risks, or in the treatment of patients who are not adequately responsive to or intolerant of alternative, conventional therapies. The purpose of this Supplemental New Drug Submission (SNDS) was to remove the second-line therapy limitation from the indication for Elidel.
What did the company submit to supports its submission?
No new safety or efficacy data were submitted to support the proposed removal of the second-line therapy limitation from the indication for Elidel. The company’s rationale was based on the safety and efficacy data provided to Health Canada in previous submissions.
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?
At the time of the cancellation, the review of the submission was nearing completion. Health Canada could not establish a positive benefit-risk-uncertainty profile of Elidel in the proposed revised indication based on the available evidence, which would have precluded issuing an approval. The sponsor chose to cancel their submission before a decision was issued.
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.
Manufacturer:
Bausch Health, Canada Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2020-12-24
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| ELIDEL | 02247238 | BAUSCH HEALTH, CANADA INC. | PIMECROLIMUS 1 % / W/W |