Regulatory Decision Summary for Beyfortus
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):
nirsevimab
Control Number:
269388
Therapeutic Area:
Passive Immunizing Agent (Human Monoclonal Antibody)
Type of Submission:
New Drug Submission (New Active Substance)
Decision issued:
Authorized; issued a Notice of Compliance in accordance with the Food and Drug Regulations
What was the purpose of this submission?
The purpose of this new drug submission was to seek authorisation for Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract infection (LRTI) in all neonates/infants during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
RSV is very common in Canada, usually causing mild, cold-like symptoms, and most infants recover in 1-2 weeks, nonetheless RSV infections can be serious especially for infants and older adults, potentially resulting in pneumonia/bronchiolitis and more serious disease with possible long-term consequences or even death.
The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.
Why was the decision issued?
The decision to authorize Beyfortus (nirsevimab) for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract infection (LRTI) in all neonates/infants during their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season was based on the efficacy and safety data presented in the submitted clinical study program.
For the first RSV season indication, Beyfortus (nirsevimab) was evaluated in two randomised, placebo-controlled trials (Study 3 and Melody), where preterm and term infants receiving it had a 79.5% relative risk reduction for medically attended RSV LRTI compared to the placebo arm, or a 77.3% relative risk reduction for hospitalization 150 days post receiving the treatment dose. The safety profile of nirsevimab was acceptable across all included studies (n = 4,441) with no specific safety signals of concern, adverse events (AEs) were generally balanced between groups, the majority of AEs nonserious or mild in severity.
For the second RSV season indication, Beyfortus (nirsevimab) was evaluated in two trials (Medley and Music), where infants and children up to 24 months of age with increased risk factors for severe RSV disease (eligible for palivizumab) were treated with it during one or two RSV seasons without any new safety concerns.
For further details about Beyfortus, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2023-04-19
Manufacturer / Sponsor:
Drug Identification Number(s) Issued:
02537206
02537214
Prescription status:
Schedule D drug
Date Filed:
2022-11-03
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| BEYFORTUS | 02537206 | SANOFI PASTEUR LIMITED | NIRSEVIMAB 50 MG / 0.5 ML |
| BEYFORTUS | 02537214 | SANOFI PASTEUR LIMITED | NIRSEVIMAB 100 MG / 1 ML |