FDA — authorised 16 March 2007
- Marketing authorisation holder: ALEXION PHARM
- Status: approved
🇺🇸 H5G1.1 in United States
FDA authorised H5G1.1 on 16 March 2007
Marketing authorisations
FDA — authorised 22 March 2024
- Application: BLA125166
- Marketing authorisation holder: ALEXION PHARM
- Indication: REMS
- Status: approved
The FDA approved H5G1.1, a drug developed by Alexion Pharmaceuticals, on 22 March 2024. The approval was granted under the standard expedited pathway, with application number BLA125166. H5G1.1 is indicated for a Risk Evaluation and Mitigation Strategy (REMS) programme. The approval marks a significant milestone in the development of this drug.
FDA — authorised 18 April 2025
- Application: BLA761333
- Marketing authorisation holder: AMGEN INC
- Indication: REMS
- Status: approved
The FDA approved H5G1.1, developed by AMGEN INC, on 18 April 2025. The approval was granted under the standard expedited pathway, with application number BLA761333. The approved indication is for a Risk Evaluation and Mitigation Strategy (REMS).
FDA — authorised 28 November 2025
- Application: BLA761340
- Marketing authorisation holder: SAMSUNG BIOEPIS CO LTD
- Indication: Efficacy
- Status: approved
H5G1.1 in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Neuroscience approved in United States
Frequently asked questions
Is H5G1.1 approved in United States?
Yes. FDA authorised it on 16 March 2007; FDA authorised it on 22 March 2024; FDA authorised it on 18 April 2025.
Who is the marketing authorisation holder for H5G1.1 in United States?
ALEXION PHARM holds the US marketing authorisation.