FDA approves cutaquig®, for pediatric patients

On December 7, the U.S. Food & Drug Administration (FDA) has approved cutaquig® [Immune globulin, Subcutaneous (Human)-hipp, 16.5% Solution] for the treatment of pediatric patients age 2 and older with primary humoral immunodeficiency (PI). The FDA previously approved cutaquig® for adults with PI. 

Patients and providers have the flexibility to administer at a lower dose more frequently or at a larger dose less frequently if desired. Patients who prefer less frequent injections may have the option of receiving therapy every other week. At the same time, physicians can prescribe daily dosing if patients respond better to more frequent therapy. 

“Cutaquig® provides enhanced convenience for a wider group of patients who want to customize therapy with their prescriber to best match patient lifestyle needs,” said Octapharma USA President Flemming Nielsen. “Octapharma is committed to providing people with immune disorders the lifesaving therapies they need. Both the addition of the pediatric indication and the flexible dosing illustrate our commitment to ensure patients have access to lifesaving products that offer a variety of choices for therapy delivery.” 

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