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Afstyla FDA Approval History

FDA Approved: Yes (First approved May 25, 2016)
Brand name: Afstyla
Generic name: antihemophilic factor (recombinant), single chain
Dosage form: for Injection
Company: CSL Behring
Treatment for: Hemophilia A

Afstyla (antihemophilic factor (recombinant), single chain, is a recombinant, antihemophilic factor indicated for the control and prevention of bleeding episodes in adults and children with hemophilia A.

FDA approval of Afstyla is based on results from the AFFINITY clinical development program which included safety and efficacy studies in adults, adolescents, and children with hemophilia A. Data showed that patients treated prophylactically had a median annualized spontaneous bleeding rate (AsBR) of 0.00, and median annualized bleeding rate (ABR) of 1.14 in adults and adolescents, and 3.69 in children. Data also showed that of 1,195 bleeds treated, 94 percent of adults and adolescents, and 96 percent of children were controlled with no more than two infusions of Afstyla weekly, with 81 percent of adult and adolescents, and 86 percent of children effectively controlled by just one infusion.

Afstyla is administered via intravenous injection. Patients should be aware that hypersensitivity reactions, including anaphylaxis, are possible and Afstyla should be discontinued immediately, and appropriate treatment administered if symptoms occur.

The most common side effects reported in clinical trials were dizziness and hypersensitivity.

Development timeline for Afstyla

May 26, 2016Approval FDA Approves Afstyla (Antihemophilic Factor (Recombinant), Single Chain) for Hemophilia A
Jul 28, 2015FDA Accepts for Review CSL Behring’s BLA for Its Novel rVIII-SingleChain Therapy for Patients with Hemophilia A

Further information

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