Shire Receives FDA Approval for Immunodeficiency Drug
Shire has received approval from the US Food and Drug Administration (FDA) for Cuvitru (immune globulin (IG) subcutaneous (human), 20% solution) in adult and pediatric patients two years of age and older with primary immunodeficiency.
The availability of Cuvitru as a high concentration, subcutaneous IG solution provides dosing flexibility that allows patients to customize therapy to best fit individual needs. Shire expects to launch Cuvitru in the US in the fourth quarter of 2016. Cuvitru was approved in 17 European countries in June of 2016. The company expects to initiate additional global regulatory submissions for the drug in late 2016 and 2017.