Fewer bleeds* with prophylaxis infusions vs. on-demand
"I'm stronger than my hemophilia."
severe hemophilia B, ages 12-71 (Factor IX activity 2% or less). Followed for up to 77 weeks, multiple characteristics of ALPROLIX were assessed, including
safety, efficacy, and pharmacokinetics:1-4
- In the once-weekly group, 63 people were given an initial dose of 50 IU/kg, which was adjusted to maintain desired Factor IX levels.
- In the individualized prophylaxis group, 29 people were initially given 100 IU/kg every 10 days and their intervals were adjusted to maintain desired Factor IX levels.
- In the on-demand group, 27 people infused as needed with doses ranging between 20 to 100 IU/kg depending on the severity of the bleed.
- In the surgical group, 12 people received ALPROLIX for bleed management in 14 major surgeries. 15 minor surgeries were also evaluated. Doses were adjusted
according to the type of surgery. 4 people in this group did not participate in the other groups.
- Powell JS, Pasi KJ, Ragni MV, et al. Phase 3 study of recombinant Factor IX Fc fusion protein in hemophilia B. N Engl J Med. 2013;369(24):2313-2323.
- US Food and Drug Administration. The FDA's drug review process: ensuring drugs are safe and effective.
http://www.fda.gov/drugs/resourcesforyou/consumers/ucm143534.htm.Accessed June 19, 2013.
- Pharmaceutical Research and Manufacturers of America. The research and development process. http://www.phrma.org/research-development-process.
Accessed June 19, 2013.
- Ator MA, Mallamo JP, Williams M. Overview of drug discovery and development. Curr Protoc Pharmacol. 2006;9(35):9.9.1-9.9.26.