Regulatory Decision Summary for Beovu
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.
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What was the purpose of this submission?
The purpose of this Supplement to a New Drug Submission is to obtain marketing authorization for Beovu (brolucizumab injection) for the treatment of diabetic macular edema. After evaluation of the submitted data package, Health Canada authorized the use of Beovu for the treatment of diabetic macular edema.
Why was the decision issued?
Authorization was based on two randomized, multi-center, double-blind, active controlled, non-inferiority studies (KESTREL and KITE). Patients (n = 926) with diabetic macular edema received either Beovu (brolucizumab) 3 mg (n = 190), Beovu (brolucizumab) 6 mg (n = 368), or aflibercept 2 mg (n = 368). The primary endpoint was the change from baseline at Week 52 in Best Corrected Visual Acuity (BCVA) as measured by the Early Treatment Diabetic Retinopathy Study (ETDRS) Letter Score. After one year of treatment, patients treated with Beovu 6 mg every 12 weeks or every 8 weeks (q12w/q8w) showed visual acuity improvement that was non-inferior to that observed in patients treated with aflibercept 2 mg every 8 weeks. Non-inferiority was not demonstrated for the Beovu 3 mg dose strength.
Beovu may cause side effects, such as eye conjunctival hemorrhage, infection/eye inflammation including retinal vasculitis, retinal artery occlusion, endophthalmitis, uveitis, etc. The side effects in patients with diabetic macular edema treated with Beovu were consistent with those reported in previous clinical trials conducted in patients with neovascular age-related macular degeneration. Those events have been captured in the product monograph of Beovu along with recommendations in the Warnings and Precautions section to help manage the risk.
Beovu is injected by a healthcare professional directly into the eyeball. The recommended dose for treatment of diabetic macular edema is 6 mg every 6 weeks for the first 5 doses. Afterward, the injection intervals may be modified to every 8 weeks or every 12 weeks, depending on the evaluation of disease activity in the eye by the treating physician.
The overall benefit-harm-uncertainty profile is favourable for Beovu at a 6 mg dose strength for the treatment of diabetic macular edema. A Notice of Compliance (NOC) was issued.
Please refer to product monograph of Beovu for more information.
Decision issued
Authorized; issued a Notice of Compliance (NOC) in accordance with the Food and Drug Regulations.