Shire Launches Cuvitru In U.S. For Primary Immunodeficiency – Quick Facts


Shire plc (SHP.L,SHPG) said it has launched Cuvitru?, the first and only subcutaneous 20 percent treatment option without proline available in the U.S. to treat adult and pediatric patients, two years of age and older, with primary immunodeficiency or PI.

Cuvitru expands Shire’s immunoglobulin portfolio of treatment options to meet the unique needs of children and adults living with primary immunodeficiency.

In September 2016, the U.S. Food and Drug Administration or FDA approved Cuvitru in as a subcutaneous immune globulin or IG replacement therapy for PI, a group of more than 300 genetic disorders in which part of the body’s immune system is missing or functions improperly, in some cases making it more difficult to fight off infections. PI affects up to six million people worldwide.

The FDA approval was based on positive results from two prospective…


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