LEXINGTON, Massachusetts, November 12, 2016 /PRNewswire/ -- Data reveals key findings onthe tolerability ofCUVITRU[Immune Globulin Subcutaneous (Human), 20% Solution]for patients,regardlessoftreatment 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. , PI affects six million people worldwide, of which approximately 250,000 reside in the U.S. , 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.  "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." As demonstrated in the clinical trials, CUVITRU offers patients 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. The data to be presented at ACAAI offers additional evidence that patients achieved the increased rate and volume, without compromising tolerability. Approximately 72% of patients in the clinical trial achieved the maximum infusion rate of 60 mL per hour per site, occurring after a median time of 3 infusions with no association between infusion rate and causally related local adverse event (AE) rates. Importantly, 99.8% infusions of CUVITRU were completed without a rate reduction, interruption, or discontinuation indicating the infusions were well tolerated. In addition, 75% of infusions delivered a volume of 30 mL per site or greater, with no association between volume per site and causally-related local AEs.  The full clinical trial results can be found in Journal of Clinical Immunology. CUVITRU is the latest product in Shire's industry-leading IG portfolio. The U.S. Food and Drug Administration approved CUVITRU in September 2016. Shire also received successful completion of a decentralized procedure to support CUVITRU approval by 17 authorities in Europe in June 2016. The company expects to initiate additional global regulatory submissions for CUVITRU in late 2016 and 2017. For more information on CUVITRU, please visit http://www.cuvitru.com. About Primary Immunodeficiency Primary immunodeficiencies (PI) are a group of more than 300 disorders in which part of the body's immune system is missing or does not function properly.  Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, the individuals are susceptible to infections, and it may take longer to recover from infections. When a defect in the immune system is inherited and genetically determined, it is called primary immune deficiency. About CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20% Solution indicated as replacement therapy for primary humoral immunodeficiency (PI) in adult and pediatric patients two years of age and older.