Presentation of tolerability data for Cuvitru [Immune Globulin Subcutaneous (Human), 20% Solution] in patients with primary immunodeficiency diseases- Shire plc

Shire plc 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 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.

See- "Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America".-Suez, D., Stein, M., Gupta, S. et al. J Clin Immunol (2016) 36: 700. doi:10.1007/s10875-016-0327-9.