Summary of Cancellation for Sotrovimab (Xevudy)*
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):
Sotrovimab
Therapeutic area:
Immune sera and immunoglobulins, for human use
Type of submission:
New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV)
Control number:
257895
Decision issued :
No decision was issued by Health Canada. The company cancelled its submission before a final decision was issued.
Date of cancellation :
2024-04-29
What was the purpose of this submission?
The purpose of this submission was to seek authorization, via the New Drug Submission with flexibilities filed for COVID-19 Drug products (NDS-CV) framework respecting the importation, sale and advertising of drugs for use in relation to COVID-19, for sotrovimab, for the treatment of mild to moderate COVID-19 in adults and adolescents (aged 12 years and older weighing at least 40 kg) who are at risk of progressing to severe COVID-19.
What did the company submit to supports its submission?
This submission was reviewed under the Interim Order (IO) (#251285), which permitted a rolling submission and rolling review at the time of the initial authorization. The initial clinical data (filed April 1, 2021) in support of sotrovimab were derived from summary reporting of the seamless phase 2/3 pivotal study VIR-7831-5001 or GSK 214367 (also known as COMET-ICE hereafter), in which the investigators stopped future enrollment at its first interim analysis (IA1) based on recommendations by an independent data monitoring committee (IDMC) due to evidence of safety and efficacy. At this point (a pre-specified data cut-off (DCO) on March 4, 2021), study data were assessed by the IDMC for safety, efficacy and futility data in approximately 41% (N = 583) of planned subjects to be recruited (N = 1,360). COMET-ICE day 29 clinical study report (CSR) was filed on January 31, 2022 and week 24 CSR was filed on May 10, 2022. Given the limitations associated with early data cutoff after the first interim analysis and relatively low numbers of participants in the pre-specified data set (N = 868 for safety, N = 583 for efficacy), the post-hoc analysis of all participants enrolled (N = 1,057) was also incorporated into the review and included in the Product Monograph information.
Under the IO, limited data in subjects <18 years were provided to support the initial authorization of the inclusion of high-risk adolescents who weigh at least 40 kg in the indication and was mainly based on extrapolation of the efficacy and safety findings in adult patients.
The remaining data provided under the NDS-CV, including the in vitro activity of sotrovimab and clinical updates were under review at the time of the DIN cancellation/withdrawal.
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 using SAP. Requests for special access to sotrovimab will continue to be considered on a case-by-case basis. For more information about the Special Access Programme refer to the programme’s Website: http://www.healthcanada.gc.ca/sap or http://www.santecanada.gc.ca/pas.
*Proposed Brand Name:
Xevudy
Manufacturer:
GlaxoSmithKline Inc.
Drug Identification Numbers issued:
N/A
Date filed:
2021-10-25