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ADYNOVI
ADYNOVI is a recombinant human coagulation factor VIII, used to treat and prevent bleeding episodes in patients with hemophilia A.
ADYNOVI is a recombinant human coagulation factor VIII, used to treat and prevent bleeding episodes in patients with hemophilia A. Used for Hemophilia A, prevention and treatment of bleeding episodes.
At a glance
| Generic name | ADYNOVI |
|---|---|
| Also known as | rurioctocog alfa pegol, rAHF-PEG |
| Sponsor | Baxalta now part of Shire |
| Drug class | Factor VIII replacement therapy |
| Target | Factor VIII |
| Modality | Biologic |
| Therapeutic area | Hematology |
| Phase | Phase 2 |
Mechanism of action
It works by replacing the deficient factor VIII in patients with hemophilia A, allowing for proper blood clotting. This helps to prevent and treat bleeding episodes, such as joint bleeds and muscle bleeds.
Approved indications
- Hemophilia A, prevention and treatment of bleeding episodes
Common side effects
- Inj site reaction
- Headache
- Nausea
Key clinical trials
- A Long-term Study of ADYNOVI/ADYNOVATE in Participants With Haemophilia A
- Pharmacokinetic Assessment of Standard Half-Life (SHL) FVIII, Extended Half-Life (EHL) FVIII, and Efanesoctocog Alfa (BIVV001) in Severe Hemophilia A (PHASE1)
- ADVATE/ ADYNOVI Hemophilia A Outcome Database (AHEAD)
- Pharmacokinetic Characterization of the Hemophilia A Population in Spain Using myPKFiT®
- Study to Compare How the Body Distributes and Excretes the Drugs Jivi (BAY 94-9027) and Adynovi in Patients With Severe Hemophilia A (Bleeding Disorder Resulting From a Lack of Blood Clotting Factor VIII) (PHASE1)
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 |
|---|---|
| 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:
- ADYNOVI CI brief — competitive landscape report
- ADYNOVI updates RSS · CI watch RSS
- Baxalta now part of Shire portfolio CI