FDA OKs expanded use of Xembify for primary immunodeficiency

Xembify (immune globulin subcutaneous, human – klhw) 20% solution is now approved for use in treatment naive patients ≥2 years of age with primary humoral immunodeficiency (PI). According to a manufacturer press release, Xembify is the first 20% SCIg product with this extended label, allowing patients to begin SCIg therapy without first having IV administration. The expanded approval also includes biweekly dosing that was supported by phase 4 clinical trial in which patients with PI treated with Xembify q2wks (vs. weekly) achieved non-inferiority in total Ig levels.