Shire files for FDA approval of Georgia manufacturing facility

Ireland-based rare diseases specialist Shire (LSE: SHP) has filed its second submission to the US Food and Drug Administration for its new plasma manufacturing facility near Covington, Georgia.

This second submission is for the manufacturing of Flexbumin (albumin [Human]), USP, 25% solution, a treatment primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions. The Georgia facility received its first FDA approval, to manufacture Gammagard Liquid (immune globulin infusion [human]) 10% solution, in June this year.

Shire's Immunology franchise has seen strong demand, with product sales increasing +13% in the second quarter of 2018 versus the prior year.