Regulatory Decision Summary for Bexsero
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.
Type of submission:
What was the purpose of this submission?
This Supplement to a New Drug Submission (SNDS) was to seek marketing authorization of Bexsero for the expanded age indications, i.e., for active immunization of individuals over 17 years of age against invasive meningococcal disease caused by by N. meningitidis serogroup B strains. The previously approved indication was for active immunization of individuals from 2 months through 17 years old.
Why was the decision issued?
Data from 8 clinical studies were included in the SNDS to support the clinical efficacy (immunogenicity) and safety of Bexsero in individuals above 17 years of age. Antibody responses in vaccine recipients were measured by a serum bactericidal antibodies assay using human complement (hSBA) as a correlate of clinical efficacy against serogroup B meningococcus.Substantial immune response to Bexsero, as measured by hSBA against four reference strains, was shown following a 2 dose schedule in subjects 18 through 25 years of age. In addition, a third dose of Bexsero can boost the immune response in subjects who received 2 doses of Bexsero at 15-24 years of age 4 years previously. No new safety signals were identified in the newly added clinical studies. Cumulative Canadian (for individuals 2 months through 17 years of age) and worldwide post-marketing experience was obtained and no special safety concerns were identified. Overall, the benefits of Bexsero outweigh the risks for prevention of individuals from 2 months through 25 years old against invasive disease caused by N. meningitidis serogroup B strains.
There were insufficient immunogenicity and safety data to support the indication for individuals over 25 year of age. At approximately 4 years after the 2-dose primary series, antibody titers against most of reference strains were declined in subjects 15 to 24 years of age. Only limited clinical data on exposed pregnant and breast-feeding women are available.
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.