FDA approves Shire’s Cuvitru

LEXINGTON, Mass. — The Food and Drug Administration has approved Shire’s latest treatment Cuvitru (immune globulin subcutaneous (human) 20% solution). The drug is indicated to treat adults and pediatric patients ages two years and older with primary immunodeficiency, a group of more than 300 genetic disorders in which a part of the immune system functions improperly or is missing. 

 

Cuvitru is able to infuse up to 60 mL per site and 60 mL per hour, per site as tolerated, which Shire said results in fewer infusion sites and shorter infusion durations. 

 

“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,” Dr. Richard Wasserman, medical director of Pediatric Allergy and Immunology at Medical City Children’s Hospital said.