🇺🇸 Evkeeza in United States

FDA authorised Evkeeza on 11 February 2021

Marketing authorisations

FDA — authorised 11 February 2021

  • Marketing authorisation holder: REGENERON PHARMACEUTICALS
  • Status: approved

FDA — authorised 11 February 2021

  • Application: BLA761181
  • Marketing authorisation holder: REGENERON PHARMACEUTICALS
  • Local brand name: EVKEEZA
  • Indication: SOLUTION — INJECTION
  • Status: approved

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Evkeeza in other countries

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

Other Metabolic approved in United States

Frequently asked questions

Is Evkeeza approved in United States?

Yes. FDA authorised it on 11 February 2021; FDA authorised it on 11 February 2021.

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

REGENERON PHARMACEUTICALS holds the US marketing authorisation.