Tolerability Data for Shire's CUVITRU Accepted for Oral Presentation at the American College Of Allergy, Asthma & Immunology Annual Meeting

LEXINGTON, Massachusetts, November 12, 2016 /PRNewswire/ --

Data reveals key findings on the tolerability of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] for patients, regardless of treatment infusion volume and rates  

Shire plc (LSE: SHP, NASDAQ: SHPG) will present additional data supporting the tolerability of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in patients two years of age and older with primary immunodeficiency (PI) diseases in North America at the 2016 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology in San Francisco. The presentation will highlight key findings on established tolerability of CUVITRU for PI patients who received CUVITRU in the Phase II/III North American clinical trial. Of note, increased infusion volumes and rates were not associated with an increase in causally-related local adverse reactions, and infusions were well-tolerated during onboarding and throughout the study.

"As the latest treatment to be added to Shire's industry-leading IG portfolio, CUVITRU exemplifies our commitment to reducing the burden of PI for patients living with this challenging, often debilitating condition," said Philip J. Vickers, Ph.D., Head of Research and Development, Shire. "As a customizable therapy, CUVITRU offers patients and physicians multiple options to tailor their IG treatment to fit their needs and preferences, such as varying the volume/site, the dosing frequency, and infusion rate."

PI is 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],[2] PI affects six million people worldwide, of which approximately 250,000 reside in the U.S.^[3],[4] Most people with PI have abnormally low or nonexistent IG levels, and may benefit from IG replacement treatment to help the body prevent infections. Since it only offers temporary protection, many people with PI require IG replacement treatment throughout their lives.^[5]

"ACAAI's annual meeting is a welcome opportunity for the immunology community to learn more about the benefits CUVITRU can offer patients with PI looking to take control of their IG treatment," said Sudhir Gupta, MD, PH.D., MACP, Chief of Basic and Clinical Immunology, and Director, Programs in Primary Immunodeficiency and Aging, at University of California, Irvine. "The data reinforces that patients can work with their physician to individualize their dosage and administration schedule, allowing for greater flexibility and control within their normal daily routine."