It took longer than expected, but the FDA has approved the first product to be manufactured at Shire's new $1.2 billion plasma plant in the U.S.
The Dublin, Ireland-based drugmaker said Thursday that the FDA has approved its Gammagard Liquid, a replacement therapy for primary humoral immunodeficiency (PI), to be manufactured at the plant in Covington, Georgia.
Commercial production began in January, and Shire expects to be distributing the injected therapy soon now that it has won approval for the facility. It also is ramping up hiring for the facility where 900 employees already work. Shire says the new facility will add 30% capacity to Shire's internal plasma manufacturing network once it is fully operational.
“The increased manufacturing capacity from the site will support Shire's growing Immunology franchise and further strengthens our ability to deliver complex therapies for patients around the world living with a range of rare and immune-mediated conditions," Matt Walker, head of technical operations for Shire.
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Shire, which has agreed to a $62 billion buyout by Japan’s Takeda, picked up the plant and Gammagard Liquid in its $32 billion buyout of Baxalta in 2016. Shire had first said in January 2017 that the 1-million-square-foot facility plant was ready for commercial production and that it hoped to soon be producing Gammagard Liquid there.
Shire expects to make a second submission to the FDA this year for development of its albumin therapy at the Covington facility. Shire's albumin therapy is primarily used as plasma-volume replacement therapy in immune disorders, trauma and other critical conditions, it said.
Sales of Shire's immunoglobulin portfolio grew 18% last year and in the first quarter of 2018 was up 12%, driven by sales of subcutaneous products.