The majority of bleeding episodes (173/187; 92.5%) resolved with 1 or 2 infusions. Subjects rated the outcomes of infusions on a pre-specified four (4) point hemostatic efficacy scale. One hundred thirty-two (132) of 187 bleeding episodes (70.6%) treated with XYNTHA were rated excellent or good in their response to initial treatment, 45 (24.1%) were rated moderate. Five [5] (2.7%) were rated no response and 5 (2.7%) were not rated.

Table 4: Summary of Response to Infusions to Treat New Bleeding Episode by Number of Infusions Needed for Resolution

In an ongoing, open-label study of XYNTHA in surgical prophylaxis, 21 of at least 25 evaluable PTPs with severe or moderately severe (FVIII:C ≤ 2%) hemophilia A undergoing major surgical procedures received XYNTHA. One (1) subject received XYNTHA for a pre-surgery pharmacokinetic assessment only and had not undergone surgery.

The results of an interim analysis on 21 of the 25 planned evaluable subjects who had undergone major surgical procedures (13 total knee replacements, 1 hip replacement, 3 synovectomies, 1 left ulnar nerve transposition release, 1 ventral hernia repair/scar revision, 1 knee arthroscopy, 1 revision and debridement of the knee after a total knee replacement) are presented in Table 5. For the 21 surgical subjects, investigator's ratings of efficacy at the end of surgery and at the end of the initial postoperative period were excellent or good for all assessments. All reported blood loss during the intra-operative and postoperative periods was rated normal with the exception of one subject who experienced iatrogenic bleeding.

Table 5: Summary of Hemostatic Efficacy

REFERENCES

15. Mann KG and Ziedens KB. Overview of Hemostasis. In: Lee CA, Berntorp EE and Hoots WK, eds. Textbook of Hemophilia. USA, Blackwell Publishing; 2005:1-4.

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