Shire Launches CUVITRU[TM] [Immune Globulin Subcutaneous (Human), 20% Solution] in the U.S. for Primary Immunodeficiency

LEXINGTON, Massachusetts, November 16, 2016 /PRNewswire/ --

CUVITRU, now available in the U.S., expands Shire's immunoglobulin portfolio of treatment options to meet the unique needs of children and adults living with primary immunodeficiency 

Shire plc (LSE: SHP, NASDAQ: SHPG) announces the launch of CUVITRU [Immune Globulin Subcutaneous (Human), 20% ution], the first and only Subcutaneous 20% treatment option without proline available in the U.S. to treat adult and pediatric patients (two years of age and older) with primary immunodeficiency (PI).

The U.S. Food and Drug Administration (FDA) approved CUVITRU in September 2016 as a subcutaneous immune globulin (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.^[1],[3] PI affects up to six million people worldwide.^[1],[2]

People living with PI often face significant challenges relating to their disease and treatment. CUVITRU offers patients flexibility and control to manage their treatment in a way that best fits their needs and condition. In clinical trials, CUVITRU was infused weekly in under an hour in one to two sites for most patients. However, CUVITRU can be administered daily to biweekly and in up to four infusion sites, based on a patient's individual needs. CUVITRU is also the only 20% subcutaneous IG treatment option with the ability to infuse up to 60 mL (12 grams) per site and up to 60 mL per hour per site, as tolerated, allowing for fewer infusion sites and shorter infusion durations compared to other conventional subcutaneous IG treatments.

"We welcome CUVITRU as a new treatment option that will help patients and families manage their PI and adapt their treatment regimen to meet their personal needs," said Fred Modell, cofounder of the Jeffrey Modell Foundation, an organization devoted to early and precise diagnosis and care of PI patients. "We commend Shire's commitment to providing a range of treatment options that aim to improve the lives of PI patients."

Perry Sternberg, Head of U.S. Commercial, Shire, said: "CUVITRU offers an important new option for patients living with PI, providing the opportunity for fewer infusion sites and shorter infusion durations. Shire has focused on making CUVITRU available quickly following FDA approval. We recognize the importance of ensuring patients have access to a broad portfolio of IG treatment options so they can choose a therapy that best fits their needs."