Last reviewed · How we verify
Elocta (EFMOROCTOCOG ALFA)
At a glance
| Generic name | EFMOROCTOCOG ALFA |
|---|---|
| Sponsor | Swedish Orphan Biovitrum AB |
| Modality | Recombinant protein |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2015 |
Approved indications
- Hereditary factor VIII deficiency disease
Common side effects
- Factor VIII inhibition
- Device-related thrombosis
- Rash papular
- Arthralgia
- Malaise
- Myalgia
- Headache
- Rash
- Dizziness
- Dysgeusia
- Bradycardia
- Hypertension
Serious adverse events
- Myocardial infarction
- Angiopathy
Key clinical trials
- A 48-Month Study to Evaluate Long-Term Effectiveness of Elocta on Joint Health
- POCUS: Hemostatic Potential and Joint Health in Patients With Severe Hemophilia A on Novel Replacement Therapies (PHASE4)
- 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)
- Prospective, Non-interventional Study to Evaluate the Effectiveness of Elocta Compared to Conventional Factor Products
- A Study to Evaluate the Real-world Usage and Effectiveness of Elocta and Alprolix in Patients With Haemophilia A or B
- Study of rFVIIIFc for Immune Tolerance Induction (ITI) in Haemophilia A Patients With Inhibitors Who Have Failed Previous ITI Therapies (PHASE4)
- Health Related Quality of Life of Youth and Young Adults With Haemophilia A (PHASE4)
- The Hemophilia Inhibitor Prevention Trial (PHASE3)
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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Elocta CI brief — competitive landscape report
- Elocta updates RSS · CI watch RSS
- Swedish Orphan Biovitrum AB portfolio CI