Baxalta announced the launch of Adynovate (antihemophilic factor [recombinant], PEGylated), after receiving approval from the Food and Drug Administration (FDA) for on-demand treatment and control of bleeding episodes, and routine prophylaxis to reduce the frequency of bleeding episodes in patients with hemophilia A aged ≥12 years.
Adynovate is the extended circulating half-life recombinant factor based on the parent molecule, Advate (antihemophilic factor [recombinant]). Adynovate temporarily replaces the missing coagulation factor VIII needed for effective hemostasis in congenital hemophilia A. Its extended terminal half-life reduces binding to the physiological factor VIII clearance receptor (LRP1).
RELATED: Nuwiq Approved for Hemophilia A in Children, Adults
A multicenter, open-label, prospective, non-randomized, two-arm clinical trial (n=137) compared the efficacy of a twice weekly prophylactic treatment regimen to on-demand treatment and determined hemostatic efficacy in the treatment of bleeding episodes over a 6-month period. In the treated population, there was a 95.3% “Excellent or good” rate of success to treat bleeding episodes. Also, a significant reduction in annualized bleed rate (ABR) was seen in patients in the prophylaxis arm vs. the on-demand arm (P<0.0001).
Adynovate is available as 250 IU, 500 IU, 1000 IU, and 2000 IU factor VIII potency per vial. Each carton contains a diluent and needleless transfer device.
For more information call (800) 423-2090 or visit Adynovate.com.