Regulatory Decision Summary for Eylea HD
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):
Aflibercept
Control Number:
272746
Brand/Product Name:
Eylea HD
Therapeutic Area:
S01
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 Supplement to a New Drug Submission (SNDS) was to obtain marketing authorization for Eylea High-Dose (HD) (aflibercept injection, 8 mg/0.07 mL) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).
The sponsor consented to information sharing between Health Canada and health technology assessment organizations as part of an aligned review pathway.
Why was the decision issued?
Clinical efficacy and safety of Eylea HD were assessed in two randomized, multi-center, double-masked, active-controlled studies which included 960 patients with wet AMD in the Study PULSAR and 640 patients with DME in the Study PHOTON. In both studies, patients treated with Eylea HD every 12 weeks or every 16 weeks showed visual acuity improvement at Week 48 non-inferior to that observed in patients treated with Eylea 2 mg every 8 weeks.
The most frequently reported adverse events in at least 2% of patients treated with Eylea HD in Study PULSAR (wet AMD) were cataract (4.6%), intraocular pressure increased (3.1%), vitreous floaters (2.7%), vitreous detachment (2.5%), and conjunctival hemorrhage (2.1%). The most frequently reported adverse events in at least 2% of patients treated with Eylea HD in Study PHOTON (DME) were vitreous floaters (4.9%), conjunctival hemorrhage (4.3%), vitreous detachment (2.9%), punctate keratitis (2.2%) and eye pain (2.0%). Overall, the safety profile of Eylea HD up to week 60 in wet AMD and DME indications appears comparable to the established profile of the original formulation (i.e. Eylea 2 mg administered every 8 weeks).
The chemistry and manufacturing information submitted for Eylea HD has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.
An updated Risk Management Plan (RMP) for Eylea HD was reviewed by Health Canada and considered acceptable.
Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.
As labelled, the benefit/risk of Eylea HD is favorable for the treatment of wet AMD and DME. Therefore, a Notice of Compliance (NOC) was recommended.
For further details about Eylea HD, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.
Date of Decision:
2024-02-02
Manufacturer/Sponsor:
Drug Identification Number(s) Issued:
02545004
Prescription Status:
Available by prescription only
Date Filed:
2023-02-24