Regulatory Decision Summary for Nimenrix

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:

Drug

Medicinal ingredient(s):

Tetravalent meningococcal serogroups A, C, W and Y conjugate vaccine (Men ACWY -TT)

Therapeutic area:

Active Immunizing Agent

Type of submission:

Supplemental New Drug Submission

Control number:

203844
What was the purpose of this submission?

 

Nimenrix® is indicated for the active immunization of individuals from 12 months to 55 years of age against invasive meningococcal diseases caused by Neisseria meningitides serogroups A, C, W-135 and Y.

The purpose of this Supplemental New Drug Submission(S/NDS) is to expand the currently approved indication for Nimenrix to include infants starting from six (6) weeks of age, as well as to update the Product Monograph (PM) on vaccination with 1 or 2 Nimenrix doses in toddlers, new booster and persistence data with a follow-up of up to 5 years after vaccination with Nimenrix, and co-administration with Prevnar 13.

 

Why was the decision issued?

 

The proposed revisions are based on several clinical studies.

Data from clinical trials allow to conclude that antibody persistence up to 5 years after single dose of Nimenrix is similar to that following vaccination with licensed meningococcal vaccines as Menjugate and Neisvac. Nimenrix induced robust responses when used as a booster.

Vaccination with Nimenrix in infants from 6 weeks of age when co-administered with Infanrix hexa (DTPa-HBVIPV/Hib) and Synflorix (PCV10) was immunogenic and well tolerated. It was also demonstrated that Nimenrix can be administered concomitantly with Prevnar 13 in the second year of life, the immune responses to Nimenrix and Prevnar 13 were not adversely affected by co-administration. It was also shown that one dose of Nimenrix at 12 months provides sufficient protection.

The benefit/risk profile for Nimenrix stayed favorable after review of all data included in this submission.

The new recommended indication is that Nimenrix is indicated for the active immunization of individuals from 6 weeks to 55 years of age against invasive meningococcal diseases caused by Neisseria meningitides serogroups A, C, W-135.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.