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FDA Approves Fibrinogen Concentrate for Congenital Fibrinogen Deficiency ROCKVILLE, Md -- January 15, 2008 -- The US Food and Drug Administration (FDA) has approved Fibrinogen Concentrate (Human [RiaSTAP]) as an orphan drug for the treatment of bleeding in patients with congenital fibrinogen deficiency. "This product offers much-needed treatment for the small number of patients with congenital fibrinogen deficiency," said Jesse Goodman, MD, FDA's Center for Biologics Evaluation and Research, Rockville, Maryland. "If bleeding occurs in the brain or other organs and is left untreated, it may lead to blood loss, organ damage and death." The drug is indicated for patients who have afibrinogenemia or hypofibrinogememia. The product is not indicated for patients with dysfibrinogenemia, who may have normal fibrinogen levels but defective fibrinogen function. The approval is based on a study of 15 patients with afibrinogenemia who achieved the target level of fibrinogen expected to prevent bleeding after they received 70 mg/kg of the drug. In addition, plasma from 14 of the 15 patients showed increased maximum clot firmness. Fever and headache were the most common adverse reactions. Clinical benefit will be further verified in a postmarketing study which will include both afibrinogenemic and hypofibrinogenemic patients. SOURCE: US Food and Drug Administration E-mail this page to a friend or colleague! To print, use this version