🇺🇸 Lyumjev in United States

FDA authorised Lyumjev on 15 June 2020

Marketing authorisations

FDA — authorised 15 June 2020

  • Application: BLA761109
  • Marketing authorisation holder: ELI LILLY AND CO
  • Status: supplemented

FDA

  • Status: approved

Lyumjev 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 Lyumjev approved in United States?

Yes. FDA authorised it on 15 June 2020; FDA has authorised it.

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

ELI LILLY AND CO holds the US marketing authorisation.