Regulatory Decision Summary for Leronlimab
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 Closure Leronlimab (Leronlimab)
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
Decision issued
No decision was issued by Health Canada. The Interim Order Respecting the Importation, Sale and Advertising of Drug for Use in Relation to COVID-19 expired on September 16, 2021. A New Drug Submission under the Food and Drug Regulations was not filed by the sponsor.
Date of closure
September 16, 2021
What was the purpose of this submission?
Leronlimab is a full-length humanized IgG4,k monoclonal antibody specific for the C-C chemokine receptor type 5 (CCR5). The purpose of this submission was to obtain market authorization for leronlimab as a treatment for patients with severe or critical COVID-19.
What did the company submit to support its submission?
The sponsor had submitted drug quality and non-clinical components. On June 15, 2021, the sponsor indicated that the clinical package would be available December 15, 2021.
What was the status of the submission when it was closed? What was Health Canadas assessment of the submission at the time of closure?
At the time of the closure, formal review of the clinical package had not begun because it was not available. This does not disqualify a sponsor from refiling the submission at a later date based on new evidence.
What consequences does the closure 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.
There are no approved clinical trials underway in Canada for the use of leronlimab in the treatment of Covid-19.
Additional information
*Proposed Brand Name:
Leronlimab