Regulatory Decision Summary for Reyvow
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: lasmiditan (*REYVOW)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The company chose to cancel its submission before a final decision was issued.
Date of cancellation
January 26, 2021
What was the purpose of this submission?
This New Drug Submission (NDS) was filed to obtain market authorization for Reyvow (lasmiditan) oral tablet for the acute treatment of migraine with or without aura in adults.
What did the company submit to support its submission?
The sponsor submitted quality, non-clinical, and clinical data packages, as well as 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?
At the time of cancellation, the review of the submission was complete. Health Canada did not identify any deficiencies in the data packages that would have precluded issuing an approval. However, Health Canada and the sponsor could not reach agreement on the interpretation of the cardiovascular data and resulting content in the Product Monograph. The sponsor made the decision to cancel the submission before a negative decision could be issued by Health Canada.
What consequences does the cancellation have for patients accessing the drug under the Special Access Programme (SAP), or via clinical trials?
Lasmiditan is not available under the SAP. The sponsor has opted to discontinue clinical trials in Canada.
Additional information
*Proposed Brand Name:
Reyvow