FDA appro for storage changes of CSL Behring's Humate-P

The US Food and Drug Administration has approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease manufactured by Germany's CSL Behring. The treatment, a protein that helps blood form the clots necessary to stop bleeding, can now be safely stored for up to two years at 77 degrees Fahrenheit. Previously, Humate-P required colder, refrigerator-level temperatures for that storage length.

Approval of this change was based on stability data submitted by the company including laboratory tests of product potency conducted under different temperatures.

"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 Goodman, Director of the FDA's Center for Biologics Evaluation and Research.