14 September 2016 - Approval follows positive data from clinical studies on efficacy and tolerability, as well as infusion time and number of injection sites.

Shire announced that the U.S. FDA has granted approval for Cuvitru [immune globulin (human), 20% solution for subcutaneous injection] in adult and pediatric patients two years of age and older. Cuvitru is a treatment for patients with primary immunodeficiency, a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly; it affects up to six million people worldwide.

Read Shire press release