Pharming receives Orphan Drug Designation for recombinant Fibrinogen from FDA
Pharming Group N.V. announced that it has received Orphan Drug Designation for recombinant human fibrinogen (rhFIB) from the US food and Drug Administration (FDA) for the treatment of bleeding in patients deficient in fibrinogen. Pharming has initiated development of recombinant human fibrinogen as a pharmaceutical product for genetic and acquired deficiencies with the orphan designation and will continue to pursue medical device development using rhFIB through partnerships.
Recombinant human fibrinogen is being developed as a replacement therapy to treat bleeding in patients with fibrinogen deficiency. Fibrinogen is a critical protein involved in the clotting of blood. Consequently, deficiency of fibrinogen can result in uncontrolled bleeding. Bleeding resulting from low levels of fibrinogen develops in numerous clinical settings including trauma, surgery, liver disease, sepsis, and cancer.
In addition to the protection provided by the Orphan Drug designation, Pharming has a portfolio of patents covering transgenic production, purification and use of various proteins, including recombinant human fibrinogen. The resulting intellectual property position provides Pharming broad protection on rhFIB for pharmaceutical and medical device applications.
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