🇺🇸 Eylea in United States

FDA authorised Eylea on 18 November 2011 · 19,528 US adverse-event reports

Marketing authorisations

FDA — authorised 18 November 2011

  • Application: BLA125387
  • Marketing authorisation holder: REGENERON PHARMACEUTICALS
  • Status: supplemented

FDA — authorised 18 August 2023

  • Application: BLA761355
  • Marketing authorisation holder: REGENERON PHARMACEUTICALS
  • Status: approved

FDA

  • Status: approved

Safety signals — FAERS

Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.

Most-reported reactions

  1. Death — 8,069 reports (41.32%)
  2. Visual Impairment — 1,980 reports (10.14%)
  3. Blindness — 1,445 reports (7.4%)
  4. Endophthalmitis — 1,282 reports (6.56%)
  5. Visual Acuity Reduced — 1,166 reports (5.97%)
  6. Eye Pain — 1,162 reports (5.95%)
  7. Vision Blurred — 1,150 reports (5.89%)
  8. Off Label Use — 1,128 reports (5.78%)
  9. Product Dose Omission Issue — 1,078 reports (5.52%)
  10. Blindness Unilateral — 1,068 reports (5.47%)

Source database →

Eylea in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Oncology approved in United States

Frequently asked questions

Is Eylea approved in United States?

Yes. FDA authorised it on 18 November 2011; FDA authorised it on 18 August 2023; FDA has authorised it.

Who is the marketing authorisation holder for Eylea in United States?

REGENERON PHARMACEUTICALS holds the US marketing authorisation.