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FDA Approves CUVITRU, Shire’s New SCIG 20% to Treat PI

The U.S. Food and Drug Administration (FDA) has approved Shire’s CUVITRU (immune globulin subcutaneous [human] 20% solution) to treat adult and pediatric patients 2 years and older with primary immunodeficiency disease (PI). CUVITRU is the only 20% subcutaneous IG (SCIG) treatment option without proline and with the ability to infuse up to 60 mL (12 grams) per site and 60 mL per hour, per site, as tolerated, resulting in fewer infusion sites and shorter infusion durations compared with other conventional SCIG treatments.

FDA approval was based on results of a Phase II/III study of CUVITRU in which 74 patients (aged 3 years to 83 years) received 4,327 infusions over a median of 380.5 days. The rate of validated serious bacterial infections was 0.012 event per patient-year, and the annualized rate of infection was 2.41 events per patient. Median IgG trough levels were greater than 14.5 g/L. The median maximum infusion rate was 60 mL per hour per site, resulting in a median infusion duration of 0.95 hours. A volume of greater than or equal to 30 mL was infused per site in 74.8 percent of infusions. Most (84.9 percent) infusions were administered using less than or equal to two infusion sites. For 99.8 percent of infusions, there was no need to interrupt or stop administration or reduce the infusion rate. No related serious adverse event (AE) occurred during treatment, and related nonserious AEs occurred at a rate of 0.036 event per infusion. The incidence of related local AEs was 0.015 event per infusion, and related systemic AEs was 0.021 event per infusion. Most were mild in severity; none was severe. Increased infusion rates or volumes were not associated with higher AE rates.

“In the clinical study, primary immunodeficiency patients tolerated CUVITRU favorably despite the use of higher infusion site volumes and more rapid rates than have been routine in the past,” said Richard L. Wasserman, MD, PhD, medical director of pediatric allergy and immunology at Medical City Children’s Hospital. “The availability of CUVITRU as a high-concentration, subcutaneous IG provides primary immunodeficiency patients with the dosing flexibility that allows them to customize their therapy to best fit their individual needs.”

CUVITRU was approved in 17 European countries in June 2016. And, the company expects to initiate additional global regulatory submissions for CUVITRU in late 2016 and 2017.

Shire Announces U.S. FDA Approval of CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] Treatment for Primary Immunodeficiency. Shire press release, Sept. 14, 2016. Accessed at

Suez, D, Stein, M, Gupta, S, et al. Efficacy, Safety, and Pharmacokinetics of a Novel Human Immune Globulin Subcutaneous, 20 % in Patients with Primary Immunodeficiency Diseases in North America. Journal of Clinical Immunology, October 2016, Volume 36, Issue 7, pp 700–712. Accessed at