Summary of Cancellation for Casirivimab and Imdevimab (Ronapreve)*
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):
Casirivimab and imdevimab
Therapeutic area:
Specific Immunoglobulins
Type of submission:
New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Control number:
256264
Decision issued:
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation:
06-21-2024
What was the purpose of this submission?
Since its interim authorization on 09 June 2021, Ronapreve (casirivimab and imdevimab), administered together as an antiviral monoclonal antibody combination, was indicated for the treatment of mild to moderate coronavirus disease 2019 (COVID-19), confirmed by direct SARS-CoV-2 viral testing, in adults and adolescents (12 years of age and older weighing at least 40 kg) who were at high risk for 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 in a rolling submission of safety and efficacy data from all three phases of an ongoing pivotal study R10933-10987-COV-2067 (NCT04425629) that used a master protocol and conducted during the early part of the COVID-19 pandemic starting on 16 June 2020 with final analysis submitted on 12 December 2022. Data from the Phase 3 Cohort 1 (nonpregnant adults ≥18 years of age) trial were used for the interim order (IO) authorization. Additional terms and conditions were attached to the market authorization to ensure appropriate oversight, manage uncertainties or mitigate risks. This included providing ongoing data on post-authorization safety and efficacy data in the face of evolving SARS-CoV-2 variants of concern including Omicron.
No adolescents (12 to 17 years of age) were included in the available clinical trials at the time of initial authorization, but preliminary population pharmacokinetic modelling and simulation predicted similar exposures following the adult dose in adolescent patients weighing more than 40 kg compared to those observed in adult participants in the study. Following initial authorization, under the IO, data from pediatric participants <18 years of age enrolled in Cohort 2 (last patient visit on 07 June 2022) and pregnant participants enrolled in Cohort 3 (last patient visit on 05 April 2022) were submitted to expand the indication to other age groups and conditions.
For the NDS-CV rolling review starting in the fall of 2021, safety and efficacy data from a second pivotal Phase 3 study R10933-10987-COV-2069 (NCT04452318) were also submitted to support subcutaneous administration in addition to the original intravenous administration, as well as preventing SARS-CoV-2 infections among household contacts of patients with COVID-19 including ongoing Cohorts A (adults and adolescents ≥12 years of age) and Cohort B (pediatric participants <12 years of age).
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?
The review of the submission was ongoing at the time of cancellation.
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 in clinical trials. Ronapreve is not being accessed under the SAP.
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:
Ronapreve
Manufacturer:
Hoffman-La Roche Limited
Drug Identification Numbers issued:
N/A
Date filed:
09-01-2021