Pavblu FDA Approval History
Last updated by Judith Stewart, BPharm on Sep 2, 2024.
FDA Approved: Yes (First approved August 23, 2024)
Brand name: Pavblu
Generic name: aflibercept-ayyh
Dosage form: Injection
Company: Amgen Inc.
Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion , Diabetic Macular Edema, Diabetic Retinopathy
Pavblu (aflibercept-ayyh) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
- Unlike Eylea (aflibercept), Pavblu is not indicated for the treatment of patients with retinopathy of prematurity.
- Pavblu is biosimilar to Eylea and does not have an interchangeability designation.
- Pavblu is administered by intravitreal injection.
- FDA approval of Pavblu was based on a comprehensive review of scientific evidence that demonstrated the product is highly similar to Eylea, and that there were no clinically meaningful differences from Eylea.
- Warnings and precautions associated with Pavblu include endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion; increases in intraocular pressure; and potential risk of arterial thromboembolic events.
- Common adverse reactions include conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and increased intraocular pressure.
- Pavblu is the fifth FDA-approved Eylea biosimilar, following the approvals of Enzeevu (aflibercept-abzv), Ahzantive (aflibercept-mrbb), Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) in 2024.
Development timeline for Pavblu
| Date | Article |
|---|---|
| Aug 23, 2024 | Approval FDA Approves Pavblu (aflibercept-ayyh), a Biosimilar to Eylea |
Further information
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