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.

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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.


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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.

For more information visit grifols.com.