Ahzantive FDA Approval History
Last updated by Judith Stewart, BPharm on July 2, 2024.
FDA Approved: Yes (First approved June 28, 2024)
Brand name: Ahzantive
Generic name: aflibercept-mrbb
Dosage form: Injection
Company: Formycon AG
Treatment for: Macular Degeneration, Macular Edema Following Retinal Vein Occlusion , Diabetic Macular Edema, Diabetic Retinopathy
Ahzantive (aflibercept-mrbb) is a vascular endothelial growth factor (VEGF) inhibitor biosimilar to Eylea indicated for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.
- Unlike Eylea (aflibercept), Ahzantive is not indicated for the treatment of patients with retinopathy of prematurity.
- Ahzantive is biosimilar to Eylea and does not have an interchangeability designation.
- Ahzantive is administered by intravitreal injection.
- FDA approval of Ahzantive 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 Ahzantive 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.
- Ahzantive is the third FDA-approved Eylea biosimilar, following the approvals of Yesafili (aflibercept-jbvf) and Opuviz (aflibercept-yszy) in 2024.
Development timeline for Ahzantive
| Date | Article |
|---|---|
| Jul 1, 2024 | Approval FDA Approves Ahzantive (aflibercept-mrbb), a Biosimilar to Eylea |
Further information
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