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Alprolix (EFTRENONACOG ALFA)
Alprolix (generic name: EFTRENONACOG ALFA) is a Recombinant protein drug developed by Swedish Orphan Biovitrum AB. It is currently FDA-approved (first approved 2016) for Hereditary factor IX deficiency disease.
Alprolix is a protein-based medication used to treat Hemophilia A and Hemophilia B, as well as other congenital bleeding disorders. It works by replacing the missing or defective coagulation factor IX in the body, which is necessary for blood clotting.
At a glance
| Generic name | EFTRENONACOG ALFA |
|---|---|
| Sponsor | Swedish Orphan Biovitrum AB |
| Modality | Recombinant protein |
| Therapeutic area | Metabolic |
| Phase | FDA-approved |
| First approval | 2016 |
| Annual revenue | 300 |
Approved indications
- Hereditary factor IX deficiency disease
Common side effects
- Headache
- Oral paresthesia
- Obstructive uropathy
- Injection site erythema
- Hypersensitivity
Serious adverse events
- Factor IX inhibition
Key clinical trials
- Dosage and PD Study of Eftrenonacog-alfa
- An International Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B
- An 18-month Low-interventional Study to Assess Joint Health in Haemophilia A and B Patients on Prophylaxis With Efmoroctocog Alfa or Eftrenonacog Alfa (PHASE4)
- A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
- A Study to Evaluate the Real-world Effectiveness and Usage of Alprolix in Patients With Haemophilia B in France
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Alprolix CI brief — competitive landscape report
- Alprolix updates RSS · CI watch RSS
- Swedish Orphan Biovitrum AB portfolio CI
Frequently asked questions about Alprolix
What is Alprolix?
What is Alprolix used for?
Who makes Alprolix?
What is the generic name of Alprolix?
When was Alprolix approved?
What development phase is Alprolix in?
What are the side effects of Alprolix?
What is Alprolix's annual revenue?
Related
- Manufacturer: Swedish Orphan Biovitrum AB — full pipeline
- Therapeutic area: All drugs in Metabolic
- Indication: Drugs for Hereditary factor IX deficiency disease
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing