FDA changes Humate-P storage conditions

WASHINGTON, Oct. 22 (UPI) -- The U.S. Food and Drug Administration approved a change in the storage conditions for Humate-P, used by people with hemophilia A or von Willebrand Disease.

The treatment is a protein that helps blood form the clots necessary to stop bleeding. The FDA said Humate-P can now be safely stored for up to two years at 77 degrees Fahrenheit. Previously, Humate-P required colder, refrigerated-level storage temperatures.

The FDA said the 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 Dr. Jesse Goodman, director of the FDA’s Center for Biologics Evaluation and Research.

Humate-P is approved for the treatment and prevention of bleeding in adult patients with hemophilia A, a rare clotting disorder. It is also approved for the treatment of spontaneous and trauma-induced bleeding and the prevention of excessive bleeding related to surgery in patients with vWD, the most common inherited bleeding disorder in the United States.

The product is manufactured by CSL Behring GmbH in Marburg, Germany.