Baxalta Presents Additional Data On Newly-Approved ADYNOVATE

(RTTNews) - Baxalta Inc. (BXLT) showcased data on the clinical experience with newly-approved hemophilia A treatment ADYNOVATE [Antihemophilic Factor (Recombinant), PEGylated] at the 57th American Society of Hematology or ASH Annual Meeting. ADYNOVATE, an extended circulating half-life recombinant Factor VIII (rFVIII) treatment for hemophilia A, was approved by the U.S. Food and Drug Administration in November.

Further analyses of the data from the ADYNOVATE pivotal trial investigated characteristics of patients who achieved zero bleeds in the study. In the pivotal trial, 40 of the 101 patients (39.6 percent) achieved zero bleeding during six months of prophylactic treatment with ADYNOVATE. While some characteristics were similar across all participants, patients without bleeding generally had fewer target joints at screening, lower median historical annualized bleeding rates, and lower incidence of blood type O.

Characteristics of Patients without Bleeding in a Pivotal Trial of Extended Half-Life, Pegylated, Full-Length Recombinant Factor VIII (BAX 855) in the Treatment of Hemophilia A.

Additional post-hoc sub analysis from the pivotal trial addressed joint bleeding patterns among patients receiving twice-weekly prophylaxis treatment with ADYNOVATE. Approximately two-thirds of previously-treated patients (PTPs) in the study (69 of 101 PTPs, 68.3 percent) receiving ADYNOVATE had at least one "target joint" when they entered the study (ankle, knee, hip, or elbow with three or more spontaneous bleeding episodes in any consecutive 6-month period).

The analysis found that ADYNOVATE was efficacious in treating breakthrough bleeds and reducing overall annualized joint bleeding rates among patients with "target joints"

Baxalta has also conducted a Phase 3 study evaluating the efficacy and safety of ADYNOVATE for the perioperative control of hemostasis among 15 patients with severe hemophilia A undergoing surgical procedures.

An interim analysis indicates that ADYNOVATE can support effective hemostatic control in this patient population for the intraoperative (during the procedure), postoperative (24 hours after completion of the procedure), and perioperative (from start of the procedure until discharge or day 14) periods. (Perioperative Efficacy of an Extended Half-Life, Pegylated, Full-Length Recombinant Factor VIII (BAX 855) in Individual Procedures.