Regulatory Decision Summary for EYLEA
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:
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
What was the purpose of this submission?
This submission was filed to extend the market authorization of EYLEA for the treatment of myopic choroidal neovascularisation (myopic CNV). A Notice of Non-compliance (NON) was originally issued for EYLEA because the main study supporting the indication was a study in a population mix that was dissimilar to that found in Canada. The sponsor had not made a persuasive enough case to show that the disease does not differ by ethnicity.
Why was the decision issued?
The safety and efficacy of EYLEA (aflibercept) was assessed in a randomized, double-masked, sham-controlled study conducted in East-Asian patients with myopic choroidal neovascularisation (myopic CNV). The results obtained from this clinical trial showed that EYLEA was superior to the sham treatment for the mean change from baseline in best corrected visual acuity (BCVA) letters in the East-Asian study population. In this response to the Notice of Non-compliance (NON), the sponsor had made an adequate case to show that an East-Asian population and a Caucasian and mixed population would respond in the same manner to aflibercept. The original concerns that risk/benefit conclusions generated in the East-Asian study population may not be relevant to a largely Caucasian population have been sufficiently addressed. In addition, the sponsor has committed to conduct a registry study to enroll 40 patients in order to better support their rationale on the lack of ethnic differences in response of myopic CNV to aflibercept therapy. No overall differences were observed in the safety in myopic CNV population and in previous authorized populations.
Therefore, the benefit/risk ratio is considered favourable. In order to ensure that the benefit continues to outweigh any risk after authorization, Health Canada has required post-approval activities to be carried out as well as a Risk Management Plan.
Decision issued
Approved; issued Notice of Compliance in accordance with the Food and Drug Regulations.