Posted by Michael Wonder on 23 Feb 2023
Aflibercept 8 mg BLA for treatment of wet age-related macular degeneration and diabetic macular oedema accepted for FDA priority review
23 February 2023 - BLA supported by two pivotal trials demonstrating non-inferior vision gains to Eylea (aflibercept) Injection, with vast majority of patients maintaining extended dosing regimens through 48 weeks.
Regeneron Pharmaceuticals today announced that the US FDA has accepted for priority review the biologics license application for aflibercept 8 mg for treatment of patients with wet age-related macular degeneration, diabetic macular oedema and diabetic retinopathy.
The FDA target action date is 27June 2023 following the use of a priority review voucher.
