Note: 6% of patients ≥12 years and 4% of patients <12 years needed ≥3 infusions to control bleeding.
Phase I/III, open-label, multicenter, crossover study in patients ≥12 years, and a phase III, open-label, multicenter study in patients <12 years.
A total of 848 bleeding episodes were treated with AFSTYLA and 835 received an efficacy assessment by the investigator. The majority of the bleeding episodes occurred in joints. The median dose per injection used to treat a bleeding episode was 31.7 IU/kg.
A total of 347 bleeding episodes were treated with AFSTYLA and received an efficacy assessment by the investigator. The majority of bleeding episodes occurred in joints. The median dose per injection used to treat a bleeding episode was 27.3 IU/kg.
Perioperative bleeding management with AFSTYLA was rated as "excellent" in 15 surgeries and "good" in 1 surgery (n=16).
Median factor consumption on the day of surgery was 89.4 IU/kg (range 40.5–108.6 IU/kg).
Note: Treating physicians rated surgical hemostatic efficacy of AFSTYLA on a 4-point scale: Excellent (hemostasis not clinically different from normal), Good (normal or mildly abnormal hemostasis), Moderate (moderately abnormal hemostasis), Poor/No response (severely abnormal hemostasis).
AFSTYLA data from a phase I/III, open-label, multicenter, crossover study in patients 12 years and over. Investigators assessed hemostatic efficacy of AFSTYLA in 13 adult/adolescent patients with severe hemophilia A who underwent a total of 16 surgical procedures.
Extraction of wisdom teeth, abdominal hernia repair, elbow replacement, ankle arthroplasty, knee replacement, circumcision, open reduction internal fixation of ankle, hardware removal from ankle, cholecystectomy, and lengthening of the Achilles tendon.