FDA Approves Change In Storage Conditions For Humate-P

Main Category: Blood / Hematology
Also Included In: Pharma Industry / Biotech Industry;  Regulatory Affairs / Drug Approvals
Article Date: 22 Oct 2007 - 12:00 PDT

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The U.S. Food and Drug Administration approved a change in the storage conditions for Humate-P, a treatment for bleeding in certain patients with hemophilia A or von Willebrand Disease (vWD).

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 L. Goodman, M.D., M.P.H., 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 adult and pediatric patients with vWD, the most common inherited bleeding disorder in the United States.

Humate-P is manufactured from human plasma obtained from screened and tested U.S. donors.

Reported adverse reactions include allergic reactions such as hives, rash, chest tightness, swelling, and shock. Blood clots have been observed in patients under treatment for vWD.

Humate-P was first approved in 1986 for the treatment and prevention of bleeding in patients with hemophilia A. It was first approved for use in patients with vWD in 1999.

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

http://www.fda.gov