Last reviewed · How we verify
Vonvendi (VONICOG ALFA)
At a glance
| Generic name | VONICOG ALFA |
|---|---|
| Sponsor | Baxalta US Inc. |
| Modality | Recombinant protein |
| Therapeutic area | Hematology |
| Phase | FDA-approved |
| First approval | 2015 |
Approved indications
- von Willebrand disorder
Common side effects
- Headache
- Vomiting
- Nausea
- Dizziness
- Generalized pruritus
- Hypertension
- Vertigo
- Tachycardia
- Infusion site paresthesia
- Hot flush
- Dysgeusia
- Tremor
Serious adverse events
- Infusion-related reaction
- Deep vein thrombosis
- Hypersensitivity/Anaphylactic reaction
Key clinical trials
- A Study on the Outcomes of Recombinant Von Willebrand Factor on Demand Treatment and Prevention and Treatment of Bleeding During and After Surgery in Adults With Inherited Von Willebrand Disease in the United Kingdom (UK)
- An Observational Study of Vonicog Alfa (rVWF) in Pediatric Participants With Von Willebrand Disease (vWD)
- A Study of Recombinant Von Willebrand Factor (rVWF) in Chinese Participants With Von Willebrand Disease (vWD) (PHASE3)
- A Study of Vonicog Alfa (rVWF) in Children With Severe Von Willebrand Disease (vWD) (PHASE3)
- A Study of Recombinant Von Willebrand Factor (rVWF) in Pediatric and Adult Participants With Severe Von Willebrand Disease (VWD) (PHASE3)
- Post Trial Access Program of TAK-577 for Von Willebrand Disease (VWD)
- A Study of Recombinant Von Willebrand Factor (rVWF) With or Without ADVATE in Children With Severe Von Willebrand Disease (VWD) (PHASE3)
- Minimize Menorrhagia in Women With Von Willebrand Disease (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
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 |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Vonvendi CI brief — competitive landscape report
- Vonvendi updates RSS · CI watch RSS
- Baxalta US Inc. portfolio CI