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:

Drug

Medicinal ingredient(s):

faricimab

Therapeutic area:

Ophthalmological

Type of submission:

New Drug Submission (NDS) (New Active Substance (NAS))

Control number:

253904
What was the purpose of this submission?

 

The purpose of this submission is to obtain marketing authorization for Vabysmo (faricimab) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).

 

Why was the decision issued?

 

Clinical efficacy and safety of Vabysmo for the treatment of wet AMD were assessed in two randomized, multi-center, double-masked, active-controlled studies (TENAYA and LUCERNE) in 1329 patients with wet AMD. After one year of treatment, patients treated with Vabysmo showed similar visual acuity improvement as patients treated with aflibercept. The visual acuity improvement were generally maintained over 60 weeks.

Clinical efficacy and safety of Vabysmo for the treatment of DME were assessed in two randomized, multi-center, double-masked, active-controlled studies (YOSEMITE and RHINE) in 1891 patients with DME. After one year of treatment, patients treated with Vabysmo showed similar visual acuity improvement as patients treated with aflibercept. The visual acuity improvement were generally maintained over 100 weeks.

Vabysmo may cause side effects, such as eye infection/eye inflammation including endophthalmitis, retinal detachment/tear, conjunctival hemorrhage, cataract, vitreous detachment, vitreous hemorrhage, increase in intraocular pressure, vitreous floaters, eye pain, etc. The side effects observed in Vabysmo clinical trials have been captured in the Vabysmo Product Monograph (PM).

The recommended dose

Vabysmo is injected by a healthcare professional directly into the eyeball.

The recommended dose for treatment of wet AMD is 6 mg every month for the first 4 months. After that, the injection intervals may be modified to 8 week, 12 weeks or 16 weeks based on the evaluation of disease activity in the eye.

The recommended dose for treatment of DME is 6 mg every month for the first 4 months. After that, the injection intervals may be modified up to 16 weeks based on the evaluation of disease activity in the eye.

As labelled, the benefit/risk of Vabysmo is favourable for the treatment of wet AMD and DME.

View the Vabysmo Product Monograph for more information.

For more information on Health Canadas decision, please view the Summary Basis of Decision.

 

Decision issued

Approved; issued a Notice of Compliance in accordance with the Food and Drug Regulations.