Status: BLA pending; marketed in European countries

Organizations involved:

CSL Behring AG – Manuf.; R&D; Tech.; Europe mark.

CSL Behring LLC – USA mark.

CSL Ltd. – Parent

Description: Haemocomplettan P, marketed by CSL in Europe, is a lyophilized (freeze-dried) concentrated formulation of pooled plasma-derived human fibrinogen, subjected to pasteurization (heat treatment in aqueous solution at 60°C for 20 hours) for viral inactivation, precipitation and purification contributing to virus removal. Albumin is added as a stabilizer.

Biological.: Fibrinogen is a protein needed to form a blood clot. See the Fibrin Sealants entry for further information about fibrionogen's involvement in blood clot formation. Fibrinogen levels in plasma determine potential clotting ability and activity, with diminished concentrations of fibrinogen limiting the body's ability to form a clot. Rarely, a person may have a normal quantity of fibrinogen, but the fibrinogen does not function as needed. Symptoms of a fibrinogen deficiency include excessive bleeding following injury, bruises, bleeding of the umbilical cord at birth and from the site of the umbilical stump in a newborn baby, and bone, joint or tissue hemorrhage. A simple blood coagulation test is used to determine fibrinogen levels and confirm a diagnosis.

Plasma for manufacture of Haemocomplettan P is obtained from donors in the U.S., Austria, Germany, both paid and unpaid.

Companies.: Haemocomplettan P was developed and is manufactured and marketed in Europe by CSL Behring AG.

Status: On July 22, 2008, CSL filed a BLA for approval of a fibrinogen concentrate, most likely identical to Haemocomplettan P, for treatment of patients with congenital deficiency of functional fibrinogen (hypofibrinogenemia).

Medical: Cryoprecipitate is currently the standard treatment for replacement of fibrinogen in acquired hypofibrinogenaemia. Purified fibronogen offers an alternative, and appears effective in the management of acquired hypofibrinogenemic states and enables rapid administration of a known fibrinogen dose in an emergency setting.

Market: The cost of fibrinogen concentrate in Europe is comparable with that of cryoprecipitate.