Regulatory Decision Summary for Trumenba
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.
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What was the purpose of this submission?
The purpose of the new drug submission was to seek marketing authorization of Trumenba for prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B.
Why was the decision issued?
A total of 11 completed clinical trials were included in the new drug submission. The efficacy of Trumenba was inferred by immunogenicity, as measured by serum bactericidal activity (hSBA) using human complement with 14 MenB test strains (4 primary strains and 10 secondary strains), in the two confirmatory Phase 3 clinical studies. Trumenba was immunogenic and was predicted to have a broad coverage in the prevention of invasive meningococcal disease (IMD) caused by Neisseria meningitidis serogroup B in individuals 10 through 25 years of age.
Trumenba is generally well tolerated. The efficacy for new emerging MenB strains and the long term efficacy for prevention of IMD remain unknown. No data are available in vulnerable populations, including children younger than 10 years of age, immunocompromised individuals, and pregnant and lactating women.
Overall, the benefits of Trumenba outweigh the risks for prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B in individuals aged 10-25 years.
For more information on Health Canadas decision, please view the Summary Basis of Decision.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TRUMENBA | 02468751 | PFIZER CANADA ULC | NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY A 60 MCG / 0.5 ML NEISSERIA MENINGITIDIS GRP B RECOMBINANT LIPOPROTEIN 2086 SUBFAMILY B 60 MCG / 0.5 ML |