Regulatory Decision Summary for HyQvia (Immunoglobulin [Human] and Recombinant Human Hyaluronidase)

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:


Medicinal Ingredient(s):

Immunoglobulin [Human], Recombinant Human Hyaluronidase

Control Number:


Brand/Product Name:


Therapeutic Area:

Immune Sera and Immunoglobulins

Type of Submission:

Supplement to a New Drug Submission

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 Supplemental New Drug Submission (SNDS) is to expand the indications of HyQvia in pediatric patients 2 years and older.

After evaluation of the submitted data package, Health Canada authorized HyQvia for the following indications.

  • HyQvia is indicated as replacement therapy for primary humoral immunodeficiency and secondary humoral immunodeficiency in adult and pediatric patients 2 years of age and older.

Why was the decision issued?

Two pediatric studies, Study 161503 and Study 161504, were provided in this SNDS submission to support the efficacy and safety of HyQvia in the pediatric patients.

In the Study 161503, only one out of 44 subjects (2.3%) reported two acute serious bacterial infections (ASBI) of bacterial pneumonia. The mean rate of ASBIs per subject-year was 0.04, with an upper limit of the 99% confidence interval (CI) of 0.21. The mean rate of ASBIs per subject-year was lower than the threshold rate of 1.0 ASBI per subject-year. In addition, Study 161504 showed a mean ASBIs rate of 0.019 ASBI events per subject-year. The results demonstrated the efficacy of HyQvia in pediatric subjects.

HyQvia was well tolerated in the pediatric PID patients. The most frequently reported related treatment emergent adverse events (TEAE) were headache and infusion site reactions such as pain and pruritis. No deaths were reported in both studies 161503 and 161504.

One subject in Study 161503 developed positive titers (≥160) for binding anti-recombinant human hyaluronidase PH20 (anti-rHuPH20). The subject remained negative for neutralizing antibodies. No safety concerns were identified. Since only one subject developed anti-rHuPH20 binding antibodies, and no clinical sequelae were observed, it is not possible to draw any definitive conclusions about the effects of the antibodies. No subjects developed binding anti-rHuPH20 antibodies with a titer ≥160 in Study 161504.

Both studies support HyQvia as a safe treatment in pediatric subjects.

Based on the submitted clinical data, the benefits of HyQvia outweigh the risks in the pediatric patients.

Date of Decision:



Takeda Canada Inc.

Drug Identification Number(s) Issued:


Prescription Status:

Schedule D drug

Date Filed: