Sevenfact FDA Approval History
Reviewed by Judith Stewart BPharm. Last updated on April 30, 2020.
FDA Approved: Yes (First approved April 1, 2020)
Brand name: Sevenfact
Generic name: coagulation factor VIIa (recombinant)-jncw
Dosage form: Injection
Company: HEMA Biologics, LLC
Treatment for: Hemophilia A or B with Inhibitors
Sevenfact (coagulation factor VIIa [recombinant]-jncw) is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents 12 years of age and older with hemophilia A or B with inhibitors (neutralizing antibodies).
- Sevenfact is the first new bypassing agent approved for the treatment and control of bleeding episodes in hemophilia A and B patients with inhibitors in over 2 decades.
- The active ingredient of Sevenfact is a recombinant analog of human FVII, which is expressed in the mammary gland of genetically engineered rabbits. Sevenfact is contraindicated in patients with known allergy or hypersensitivity to rabbits or rabbit proteins.
- The Sevenfact product label carries a boxed warning advising the risk of serious arterial and venous thrombotic events. Patients receiving Sevenfact should be monitored for signs or symptoms of activation of the coagulation system and for thrombosis.
- Sevenfact is administered via intravenous injection. Dose and duration of treatment is dependent on the location and severity of the bleeding, need for urgent hemostasis, frequency of administration, and known patient responsiveness to FVIIa-containing bypassing agents during prior bleeding events.
- The most common adverse reactions (incidence ≥1%) reported in clinical trials for Sevenfact were headache, dizziness, infusion-site discomfort, infusion-site hematoma, infusion-related reaction, and fever.
Development Timeline for Sevenfact
|Apr 6, 2020||Approval FDA Approves Sevenfact [coagulation factor VIIa (recombinant)-jncw] for Treatment and Control of Bleeding Episodes Occurring in Adult and Adolescent Hemophilia A and B Patients with Inhibitors|
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