The Food and Drug Administration (FDA) has approved Xembify (immune globulin subcutaneous, human- klhw; Grifols), a 20% immune globulin solution, for the treatment of primary humoral immunodeficiency in patients 2 years of age and older that includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency, X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
The approval was based on a prospective, open label, single arm, multicenter clinical trial that evaluated the safety and efficacy of Xembify compared with Gamunex-C. The primary efficacy outcome was annualized serious bacterial infection rate during the 6 months on Xembify.
Results showed the annual rate of serious bacterial infections for Xembify was 0.05 events per subject-year (1 event in 20 subject-years) which was found to be lower than 1.0 serious bacterial infections/subject-year, the threshold specified as effective. Serious bacterial infections included bacteremia/sepsis, bacterial meningitis, bacterial pneumonia, osteomyelitis/septic arthritis, or visceral abscess.
Regarding safety, the most common treatment-emergent adverse events were local infusion site reactions (eg, erythema, pain, edema, pruritus) and systemic reactions including cough and diarrhea.
The Company plans to launch Xembify in the US in the last quarter of 2019. The product will be available as a 200mg/mL protein solution for subcutaneous infusion in 5, 10, 20, and 50mL single-use vials.
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