🇺🇸 Ebglyss in United States

FDA authorised Ebglyss on 13 September 2024

Marketing authorisations

FDA — authorised 13 September 2024

Application: BLA761306
Marketing authorisation holder: ELI LILLY AND CO
Local brand name: EBGLYSS
Indication: INJECTABLE — INJECTION
Status: approved

The FDA approved Ebglyss, a new molecular entity, on 13 September 2024, under the standard expedited pathway. The marketing authorisation holder is ELI LILLY AND CO. The indication for Ebglyss is Type 1, which is a new molecular entity. The application number for this approval is BLA761306.

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FDA

Marketing authorisation holder: ELI LILLY AND CO
Status: approved

Ebglyss in other countries

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

Other Immunology approved in United States

Frequently asked questions

Is Ebglyss approved in United States?

Yes. FDA authorised it on 13 September 2024; FDA has authorised it.

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

ELI LILLY AND CO holds the US marketing authorisation.