Fidanacogene elaparvovec
Orphan Drug Cold Chain RequiredFDA Approved (2024)
Description
A one-time AAV gene therapy delivering a high-activity factor IX variant for moderate-to-severe hemophilia B. FDA-approved April 2024.
Indications & Therapeutic Use
Hemophilia B
Linked Diseases:
Global Availability (1 countries)
| Country | Access Route | Regulatory Pathway | Lead Time | Status |
|---|---|---|---|---|
| Standard Marketing Authorization | — | — | Approved |
Available Through
This drug is available for procurement through the following fulfilment partner.
Fulfilment Partner
Fidanacogene elaparvovec
| Generic Name | fidanacogene elaparvovec |
| Brands | 1 brand available |
| Active Ingredient | fidanacogene elaparvovec |
| Drug Class | Hemophilia B |
| Manufacturer | Pfizer |
| Orphan Status | Yes — Orphan Drug |
| Cold Chain | Required |
| Reg. Status | FDA Approved (2024) |
| Countries | 1 countries |
Authority Signals
Last Verified7/24/2026
Data ConfidenceHigh (AI + Pharmacist)
Source Citations2 Validated Nodes