Regulatory Decision Summary for HyQvia

The purpose of this Supplement to a New Drug Submission (SNDS) is to expand the indications authorized for HyQvia, filed by Takeda Canada Inc., to include the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP).

After evaluation of the submitted data package, Health Canada authorized HyQvia for the following indication:

• HyQvia is indicated for CIDP as maintenance therapy after stabilization with intravenous immunoglobulin (IVIG) to prevent relapse of neuromuscular disability and impairment in adults.

HyQvia was previously authorized as replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult and pediatric patients 2 years of age and older.

HyQvia has been studied in one pivotal phase 3 study 161403 (ADVANCE-1) in adults with chronic inflammatory demyelinating polyneuropathy (CIDP). The study enrolled patients ≥18 years of age (male or female) at the time of screening who had a documented diagnosis of definite or probable CIDP as per the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS) 2010 criteria and have been on a stable intravenous immunoglobulin treatment for at least 12 weeks before screening.

Treatment with HyQvia resulted in a lower proportion of patients who experienced a relapse compared to placebo. From the clinical perspective, considering the added burden of CIDP relapse on functional capacity and disease progression, the level of reduction in relapse risk demonstrated in the clinical trial is considered clinically meaningful.

The safety profile of HyQvia was evaluated in 100 patients with CIDP who were treated with either HyQvia or placebo, and who were exposed for at least 24 weeks. The most commonly reported adverse reactions are injection and infusion site reactions, nausea, headache and fatigue. The safety profile of HyQvia in patients with CIDP is consistent with the known safety profile of HyQvia for previously authorized indications.

Based on the clinical data submitted, the benefit-risk profile of HyQvia is considered favourable when used in adults with CIDP. Therefore, a Notice of Compliance (NOC) was recommended. 

An updated Risk Management Plan (RMP) for HyQvia was reviewed by Health Canada and considered acceptable. 

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable. 

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