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FDA Approves Pavblu

FDA Approves Pavblu (aflibercept-ayyh), a Biosimilar to Eylea

August 23, 2024 – The U.S. Food and Drug Administration (FDA) has announced the approval of Pavblu (aflibercept-ayyh) 2 mg injection (single-dose prefilled syringe and single-dose vial) for intravitreal administration.

Pavblu is 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), and diabetic retinopathy (DR).

Pavblu is biosimilar to the reference product Eylea, and does not have an interchangeability designation.

The FDA granted Amgen, Inc. approval for Pavblu based on analytical and preclinical in vitro study data, and clinical data.

About Pavblu (aflibercept-abzv)

The active ingredient in Pavblu is aflibercept. Aflibercept is a recombinant fusion protein that works by blocking vascular endothelial growth factor (VEGF) to prevent abnormal blood vessel growth within the eye, and to slow down or reduce damage to the retina and help preserve vision.

INDICATIONS
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)

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS
• Ocular or periocular infection
• Active intraocular inflammation
• Hypersensitivity

WARNINGS AND PRECAUTIONS
• Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately.
• Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection.
• There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors.

ADVERSE REACTIONS
The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased.

This is not the complete list of all the safety information for Pavblu.

Reference: Pavblu Prescribing Information https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761298s000lbl.pdf Accessed August 23, 2024

Posted: August 2024

Pavblu (aflibercept-ayyh) FDA Approval History

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