Regulatory Decision Summary for Ixchiq

IXCHIQ, a live-attenuated chikungunya virus (CHIKV) vaccine, has been approved in Canada for active immunization in individuals 18 years and older for the prevention of disease caused by the chikungunya virus (CHIKV). This Supplement to a New Drug Submission (SNDS) is to further expend the indication to adolescents (12 years to 17 years old).

The target disease for IXCHIQ is chikungunya or chikungunya fever, which is caused by chikungunya virus (CHIKV) that is transmitted through the bite of infected mosquitos, which are the primary vectors of CHIKV.

Chikungunya affects all genders and age groups and often results in high fever (39°C and 40°C), headache (almost 70% of patients), and persistent joint pain (about 40% of patients). Severe recurrent joint pain may persist for months to years post-infection. There is no specific antiviral treatment for the disease.

This SNDS included one phase III study to support the proposed age expansion (12 years and older) of the approved indication for IXCHIQ. This study evaluated CHIKV-specific antibody response and safety in healthy adolescents (12 to 17 years old) after vaccination with a single adult dose of IXCHIQ or placebo.

As shown in the study, in adolescents who had no prior infection with CHIKV, vaccination with IXCHIQ induced a robust CHIKV-specific antibody response which remained at significant levels higher than the predicted threshold for prevention of CHIKV infection up to 180 days after vaccination. The majority of adverse reactions were mild or moderate. The observed pattern of CHIKV-specific antibody response and safety profile after vaccination with IXCHIQ in the adolescents are similar to those observed in IXCHIQ-vaccinated adults who have no prior CHIKV infection. The above-noted observations are the basis for recommending market authorization for IXCHIQ in individuals aged 12 years or older.

The labelling information submitted met all applicable regulations and guidance.

The Canadian Risk Management Plan (RMP) for IXCHIQ (Chikungunya Vaccine, live, attenuated) was submitted to Health Canada as part of the Supplement to a New Drug Submission (SNDS; Control # 290364). The RMP is designed to describe known and potential safety issues, to present the monitoring plan and when needed, to describe measures that will be put in place to minimize risks associated with the product. Upon review, the RMP is considered to be acceptable and identified appropriate monitoring (pharmacovigilance) activities and risk minimization measures for IXCHIQ. This includes providing information in the product monograph and identifying populations and areas where more data are needed. Results related to the safety and effectiveness of IXCHIQ from ongoing and planned studies will be submitted in Periodic Safety Update Reports (PSURs) as they become available.

For further details about Ixchiq, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.