Shire Gets FDA OK for Tech Transfer for Drug-Product Mfg Process to Vienna FacilityBy
The US Food and Drug Administration has granted approval for Shire’s technology transfer of the drug-product manufacturing process for Cinryze (C1 esterase inhibitor [human]) to its manufacturing site in Vienna, Austria. Cinryze is an injectable prescription medicine that is used to help prevent swelling and/or painful attacks in teenagers and adults with hereditary angioedema, a rare genetic disease.
Shire will begin commercial manufacturing of the Cinryze drug product in Vienna in the first quarter of 2018. Cinryze will also continue to be produced by a third-party supplier.