Shire (SHPG) Receives FDA Approval for CUVITRU as Primary Immunodeficiency Treatment

September 14, 2016 7:01 AM EDT

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Shire plc (Nasdaq: SHPG) announced that the United States Food and Drug Administration (FDA) has granted approval for CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution] in adult and pediatric patients two years of age and older. CUVITRU is a treatment for patients with primary immunodeficiency (PI), a group of more than 300 genetic disorders in which part of the body's immune system is missing or functions improperly; it affects up to six million people worldwide.

With the approval of CUVITRU, Shire now has the broadest portfolio of intravenous and subcutaneous immunolglobulin (IG) products, including the only once-a-month subcutaneous treatment option. CUVITRU is the only 20% subcutaneous IG 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 to other conventional subcutaneous IG treatments. Regardless of infusion rate or volume per site, CUVITRU was generally associated with a low incidence of local adverse and systemic reactions (0.022/infusion and 0.042/infusion, respectively) in the North American clinical study.

"In the clinical study, primary immunodeficiency patients tolerated CUVITRU favorably despite the use of higher infusion site volumes and more rapid infusion rates than have been routine in the past," said Richard L. Wasserman, M.D., Ph.D., 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."

"As the national patient organization dedicated to people with primary immunodeficiency, the Immune Deficiency Foundation is delighted to see new treatment options that can address patients' clinical priorities as well as their personal preferences, particularly in terms of dosing and administration," said Marcia Boyle, President and Founder of the Immune Deficiency Foundation. "We commend Shire's focus on innovation and continued commitment to supporting the PI community."

The approval follows the recent publication of a Phase II/III study of CUVITRU among North American patients in the Journal of Clinical Immunology. Shire expects to launch CUVITRU in the U.S. in the coming weeks. CUVITRU was approved in 17 European countries in June of 2016. The company expects to initiate additional global regulatory submissions for CUVITRU in late 2016 and 2017.

"As CUVITRU is now approved in the U.S. following European approval earlier this year, Shire's broad IG treatment portfolio offers a wide range of options to help physicians tailor treatment regimens to meet the priorities of their patients managing these life-long disorders," said Perry Sternberg, Head of U.S. Commercial, Shire. "We look forward to making CUVITRU available to the community this fall."

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