LONDON (Alliance News) - Pharmaceutical company Shire PLC on Thursday said it has filed a submission to the US Food & Drug Administration for approval to manufacture Flexbumin at its new facility.
Flexbumin is used as a plasma-volume replacement therapy for patients with immune disorders, trauma, and other conditions. It restores and maintains the volume of a patient's blood and contains human albumin, a common component of blood plasma.
This is the second of Shire's manufacturing applications relating to the plasma manufacturing facility, which is located in the US state of Georgia. In June, the FDA approved the manufacturing of Gammagard liquid at the facility. Gammagard is used to replace antibodies in immunodeficient patients.
Shire said its immunology franchise has experienced "strong demand". with product sales up 13% in the second quarter of 2018 from the prior year.
The pharma company intends to expand its plasma collection network in Georgia through its BioLife Plasma Services subsidiary, which collects human plasma for use in immunology manufacturing products at the facility.
Shares in Shire were down 1.5% at 4,420.20 pence on Thursday afternoon.
