BLA 761298, held by Amgen Inc. Aflibercept-Ayyh.
As of Nov 13, 2026, BLA 761298 (Pavblu), held by Amgen Inc, was first approved by FDA on Oct 22, 2026, with 1 approved supplement and 0 published complete response letters.
PAVBLU is indicated for the treatment of: PAVBLU is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) 1.1 Neovascular (Wet) Age-Related Macular Degeneration (AMD) 1.2 Macular Edema Following Retinal Vein Occlusion (RVO) 1.3 Diabetic Macular Edema (DME) 1.4 Diabetic Retinopathy (DR)
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2026 | Original application | Approved | |
| Aug 23, 2024 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Pavblu2 mg (0.05 mL of 40 mg/mL) · injectable;injection | Aflibercept-Ayyh | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 22, 2026 | Original application | Approved | |
| Apr 28, 2026 | Supplement 5Bioequivalence | Approved | |
| Aug 23, 2024 | Original application | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
