Tolerability Data for Shire's CUVITRU Accepted for Oral Presentation at the American College Of Allergy, Asthma & Immunology Annual Meeting - Seite 2

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.^[6] 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.^[1] 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.^[2]