Regulatory Decision Summary for Vabysmo
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:
Contact:
Medicinal Ingredient(s):
Farcimab
Control Number:
278042
Brand/Product Name:
Vabysmo
Therapeutic Area:
Ophthalmologicals
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?
After evaluation of the submitted data package, Health Canada authorized Vabysmo (faricimab) for the treatment of macular edema secondary to retinal vein occlusion (RVO).
Vabysmo previously received market authorization for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME). Please refer to the Product Monograph for Vabysmo for more information.
Why was the decision issued?
Retinal vein occlusion (RVO) secondary to macular edema is a chronic and progressive retinal vascular disorder, characterized by an increase in intraluminal pressure within the retinal vein. This leads to reduced retinal perfusion and ischemia, resulting in upregulation and secretion of vascular endothelial growth factor (VEGF) and angiopoietin-2 (Ang-2). Vabysmo (faricimab) selectively binds to VEGF and Ang-2, providing a pharmacotherapy option for the treatment of RVO.
Authorization of Vabysmo (faricimab) for the treatment of RVO was based on two identical phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group, 2-part non-inferiority studies. Patients (n = 1,282) with RVO disease received either 6 mg faricimab (n = 660) or comparator, 2 mg aflibercept (n = 660) intravitreal injections every 4 weeks from Day 1 through Week 20 (6 injections).
The primary efficacy endpoint measure was the change from baseline in best corrected visual acuity (BCVA) at Week 24. Both studies met the primary endpoint showing non-inferiority of faricimab to aflibercept at Week 24.
The safety profile of Vabysmo in patients with macular edema secondary to RVO was consistent with the other authorized indications. There were no new risks identified or serious safety concerns, and the incidence of serious ocular AEs was low.
Overall, the benefit-risk profile of Vabysmo (faricimab) used in the treatment of patients with macular edema secondary to retinal vein occlusion (RVO), is deemed favourable until Week 24 (6 months) using the proposed fixed dose posology. The long-term benefit-risk profile of Vabysmo for this indication remains to be characterized.
For further details about Vabysmo, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2024-07-24
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
N/A
Prescription Status:
Available by prescription only
Date Filed:
2023-08-08