The U.S. Food and Drug Administration (FDA) recently approved revised storage conditions for Humate-P®, a plasma-derived factor VIII/von Willebrand factor product used in the treatment and prevention of bleeds in patients with hemophilia and von Willebrand disease. Until now, Humate-P®, which is manufactured by CSL Behring, needed to be maintained at colder, refrigerated temperatures. With the new approval, it can now be kept safely for up to two years at 77 degrees Fahrenheit.
“The change in storage conditions will help patients, their families and treating physicians better manage the product, especially as part of medically supervised home treatment programs,” said Jesse L. Goodman, MD, MPH, director of the FDA’s Center for Biologics Evaluation and Research.
Source: FDA news release dated October 19, 2007