FDA Approves Pavblu, a Biosimilar to Eylea
The U.S. Food and Drug Administration (FDA) announced the approval of Pavblu (aflibercept-ayyh) 2mg injection (single-dose prefilled syringe and single-dose vial) for intravitreal administration.
- Pavblu is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with:
o Neovascular (Wet) Age-Related Macular Degeneration (AMD)
o Macular Edema Following Retinal Vein Occlusion (RVO)
o Diabetic Macular Edema (DME)
o 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.
- 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.
Source: FDA
