The FDA has approved factor VIII concentrate (Corifact, CLS Behring) as an Orphan Drug for the treatment of patients with hereditary-related factor-VIII deficiency.
The hereditary factor VIII-related deficiency is very rare. Corifact was approved based on a study of 14 persons, including children. Most Nebenwirkugnen were hypersensitivity reactions, chills, Fever, arthralgia, headache, increased thrombin-antithrombin levels and increased liver enzyme levels. During the application, patients may develop antibodies against the product that can be ineffective.
Source:
press release the FDA of 17 February 2011
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