FDA — authorised 27 August 2015
- Application: BLA125522
- Marketing authorisation holder: AMGEN INC
- Local brand name: REPATHA
- Indication: INJECTABLE — INJECTION
- Status: approved
🇺🇸 Evolocumab Auto-Injector [Repatha] in United States
FDA authorised Evolocumab Auto-Injector [Repatha] on 27 August 2015
Marketing authorisations
FDA
- Status: approved
Evolocumab Auto-Injector [Repatha] in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Frequently asked questions
Is Evolocumab Auto-Injector [Repatha] approved in United States?
Yes. FDA authorised it on 27 August 2015; FDA has authorised it.
Who is the marketing authorisation holder for Evolocumab Auto-Injector [Repatha] in United States?
AMGEN INC holds the US marketing authorisation.