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Aflibercept - Bayer/Regeneron Pharmaceuticals/Sanofi

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Drug Profile

Aflibercept - Bayer/Regeneron Pharmaceuticals/Sanofi

Alternative Names: aflibercept [genetical recombination]; AVE-0005; BAY-865321; EYLEA; Eylea; EYLEA HD; EYLEA® solution for intravitreal injection; Eylia; REGN3; Vascular endothelial growth factor Trap; Vascular endothelial growth factor Trap-R1R2; VEGF Trap (R1R2); VEGF Trap-Eye; Wetlia; Zaltrap; Ziv-aflibercept

Latest Information Update: 23 Jun 2025

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At a glance

  • Originator Regeneron Pharmaceuticals
  • Developer Bayer; Bayer HealthCare Pharmaceuticals; Bayer Yakuhin; Centre Oscar Lambret; GERCOR; Greater Houston Retina Research; Guys Hospital; Hellenic Cooperative Oncology Group; Moorfields Eye Hospital; National Cancer Institute (USA); Regeneron Pharmaceuticals; Roche; Sanofi; sanofi-aventis; Tufts Medical Center; University of Ulm
  • Class Antineoplastics; Eye disorder therapies; Immunoglobulin Fc fragments; Immunoglobulin fragments; Recombinant fusion proteins
  • Mechanism of Action Placenta growth factor inhibitors; Vascular endothelial growth factor A inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Glaucoma; Retinopathy of prematurity
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Branch retinal vein occlusion; Central retinal vein occlusion; Choroidal neovascularisation; Colorectal cancer; Diabetic macular oedema; Diabetic retinopathy; Glaucoma; Retinal oedema; Retinopathy of prematurity; Wet age-related macular degeneration
  • Phase III Polypoidal choroidal vasculopathy
  • Phase II Central serous chorioretinopathy; Graves ophthalmopathy; Retinal disorders
  • No development reported Malignant ascites; Non-Hodgkin's lymphoma; Ovarian cancer; Solid tumours
  • Discontinued Non-small cell lung cancer; Pancreatic cancer; Prostate cancer

Most Recent Events

  • 27 May 2025 Bayer completes a phase III QUASAR trials in Retinal oedema in USA, United Kingdom, Turkey, Turkey, Thailand, Switzerland, Spain, Slovakia, Serbia, Portugal, Poland, Malaysia, Lithuania, Latvia, South Korea, Japan, Italy, Hungary, Israel, Germany, Georgia, France, Estonia, Czech Republic, Bulgaria, Bulgaria, China, Austria, Australia (Intravitreous) (NCT05850520)
  • 29 Apr 2025 The US FDA sets PDUFA date of 19/08/2025 for sBLA review for broadening the dosing schedule to include every 4-week dosing across approved indications
  • 29 Apr 2025 The US FDA accepts sNDA for aflibercept for Retinal oedema for priority review

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