Regulatory Decision Summary for Takhzyro
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):
Lanadelumab injection
Therapeutic area:
Other Hematological Agents
Type of submission:
New Drug Submission
Control number:
213920
What was the purpose of this submission?
- The purpose of this submission was to seek market authorization for Takhzyro (lanadelumab injection) for the routine prevention of hereditary angioedema (HAE) attacks in adolescents and adults.
- After evaluation of the submitted data package, Health Canada authorized Takhzyro (lanadelumab injection) for the routine prevention of hereditary angioedema (HAE) attacks in adolescents and adults.
Why was the decision issued?
- Hereditary angioedema (HAE) is a rare genetic disorder.
- Authorization was based principally upon a single phase 3, multicentre, randomized, double-blind, placebo-controlled study (HELP Study; DX-2930-03). Patients with type I or II hereditary angioedema (HAE) received either Takhzyro 300mg twice monthly (n = 27) or placebo (n = 41) during a 26 week treatment period.
- The primary efficacy endpoint was the number of attacks (e.g., painful swelling often affecting the skin or mucosal tissues of the face, upper airway, gut, and limbs) during the treatment period (Day 0 through Day 182). Takhzyro reduced the rate of attacks by 86.8% compared to placebo following 26 weeks of treatment. Additionally, Takhzyro reduced the rate of attacks requiring relief treatment by 87.3% and the rate of attacks categorized as moderate to severe by 83.5%.
- The most common adverse reactions (ADRs) reported in at least 1% of patients treated with Takhzyro were injection site reactions (52%), myalgia (6%), dizziness (5%), increased liver enzymes (4%), rash (2%), and hypersensitivity (1%).
- The recommended dose of Takhzyro is 300 mg every 2 weeks. A dosing interval of 300 mg every 4 weeks may be considered if the patient is well-controlled (e.g., attack free) for more than 6 months. View the Takhzyro Product Monograph for details.
- Health Canada granted this application priority review status.
Decision issued
Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.
Related Drug Products
| Product name | DIN | Company name | Active ingredient(s) & strength |
|---|---|---|---|
| TAKHZYRO | 02480948 | TAKEDA CANADA INC | LANADELUMAB 300 MG / 2 ML |