FDA Approves Grifols Treatment for Rare Bleeding Disorders

Rare Daily Staff

The U.S. Food and Drug Administration has approved Grifols’ fibrinogen concentrate Fesilty for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.​

Congenital fibrinogen deficiency (CFD) is a rare inherited condition present from birth that is caused by genetic mutations affecting the production or function of fibrinogen. Produced in the liver, fibrinogen is a plasma protein that is essential for blood clotting and wound healing. Insufficient fibrinogen levels impede the body’s ability to control bleeding, particularly during acute bleeding events.

Fesilty is a human blood coagulation factor indicated for the treatment of acute bleeding episodes in pediatric and adult patients with congenital fibrinogen deficiency, including hypo- or afibrinogenemia.

Treatment options for low fibrinogen levels include fresh frozen plasma, cryoprecipitate, or fibrinogen concentrate. Cryoprecipitate and fresh frozen plasma contain additional proteins and components that are not necessary for fibrinogen replacement and often require infusions of large volumes to achieve adequate fibrinogen levels.​

Grifols’ fibrinogen concentrate is a highly purified product with a precisely defined amount of fibrinogen, enabling rapid and predictable restoration of fibrinogen levels, an important benefit in critical bleeding events.

The United States is the second country to approve this new fibrinogen concentrate. It was first approved in Germany in November, where it is being commercialized by Grifols subsidiary Biotest under the brand Prufibry.