Summary of Cancellation for Regdanvimab (*Regkirona)
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):
Regdanvimab
Therapeutic area:
Specific Immunoglobulins
Type of submission:
New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Control number:
252929
Decision issued:
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
2024-07-31
What was the purpose of this submission?
The purpose of the submission was to seek market authorization, via the NDS-CV framework respecting the importation, sale and advertising of drugs for use in relation to COVID-19, for regdanvimab for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), confirmed by direct SARS-CoV-2 viral testing, in adults who are at high risk of progressing to hospitalization and/or death.
What did the company submit to supports its submission?
The sponsor submitted drug quality, pre-clinical and clinical components. The pivotal clinical safety and efficacy information consisted of Part 1 and Part 2 of Study CT-P59 3.2, which was a Phase 3 randomized, double‑blind, placebo-controlled clinical trial to assess the efficacy and safety of regdanvimab in combination with standard of care in outpatients with SARS-CoV-2 infection.
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 ongoing. The Sponsor chose to cancel their submission for business reasons.
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 accessing regdanvimab via SAP or clinical trials.
Requests for special access to regdanvimab will continue to be considered on a case-by-case basis. For more information about the Special Access Programme refer to the programme’s web site: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas.
*Proposed Brand Name:
Regkirona
Manufacturer:
Celltrion Healthcare Co. Ltd.
Drug Identification Numbers issued:
N/A
Date filed:
2021-05-28