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FDA Approves Afstyla for Hemophilia A
CSL Behring news release; 2016 May 26
The FDA has approved Afstyla for adults and children with hemophilia A.
Indications: Afstyla is indicated in adults and children with hemophilia A for:
• On-demand treatment and control of bleeding episodes.
• Routine prophylaxis to reduce the frequency of bleeding episodes.
• Perioperative management of bleeding.
Dosage and administration:
• Adults and adolescents (≥12 years), start with 20 to 50 IU per kg 2 to 3 times weekly.
• Children (<12 years), start with 30 to 50 IU per kg 2 to 3 times weekly.
Efficacy and safety: Approval is based on results from the AFFINITY clinical development program, which showed a median annualized spontaneous bleeding rate of 0.00 in adults, adolescents, and children. The median annualized bleeding rate was 1.14 in adults and adolescents, and 3.69 in children.
Side effects/risks: The most common adverse reactions reported in clinical trials were dizziness and hypersensitivity.
Citation: U.S. FDA Approves CSL Behring’s AFSTYLA: The first and only recombinant factor VIII single chain therapy for hemophilia A [news release]. King of Prussia, PA: CSL Behring; May 26, 2016. http://www.cslbehring.com/newsroom/AFSTYLA-for-hemophilia-A-receives-fda-approval. Accessed June 6, 2016.
Afstyla [package insert]. King of Prussia, PA: CSL Behring 2016. http://labeling.cslbehring.com/PI/US/Afstyla/EN/Afstyla-Prescribing-Information.pdf. Accessed June 6, 2016.