FDA — authorised 20 December 2024
- Application: BLA761315
- Marketing authorisation holder: NOVO NORDISK INC
- Local brand name: ALHEMO
- Indication: Injectable — Subcutaneous
- Status: approved
🇺🇸 ALHEMO in United States
FDA authorised ALHEMO on 20 December 2024
Marketing authorisations
FDA — authorised 31 July 2025
- Application: BLA761428
- Marketing authorisation holder: NOVO NORDISK INC
- Local brand name: ALHEMO
- Indication: SOLUTION — INJECTION
- Status: approved
FDA
- Status: approved
ALHEMO in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Other approved in United States
Frequently asked questions
Is ALHEMO approved in United States?
Yes. FDA authorised it on 20 December 2024; FDA authorised it on 31 July 2025; FDA has authorised it.
Who is the marketing authorisation holder for ALHEMO in United States?
NOVO NORDISK INC holds the US marketing authorisation.