FDA approves 20% subcutaneous immunoglobulin therapy

The FDA has granted marketing approval to Hizentra, a 20% immunoglobulin subcutaneous liquid for treating patients with primary immunodeficiency.

The product, from CSL Behring, was approved after demonstrating favorable efficacy, safety and tolerability profiles in 38 adult and pediatric patients who had previously received IV immunoglobulin treatments every three or four weeks. Patients were switched to weekly subcutaneous administration of Hizentra for 15 months and Behring officials said that those on the treatment suffered no serious infections over the test period.

The most common drug-related adverse events, observed in 5 % or more of subjects in the clinical study, were local injection-site reactions, headache, vomiting, pain, and fatigue.

Hizentra is contraindicated for patients with a history of anaphylactic response to immune globulin preparations, and in individuals with selective immunoglobulin A deficiency who have known antibody against IgA and a history of hypersensitivity. It is also contraindicated in patients with hyperprolinemia.

Because the product is derived from human plasma, viruses and the Creutzfeldt-Jakob disease agent may be transmitted, though the likelihood of such transmissions is small, according to the company press release.

Reactions associated with IV immunoglobulin treatment, including renal dysfunction or failure, thrombotic events, aseptic meningitis syndrome, hemolysis or transfusion-related acute lung injury also may occur with the use of Hizentra.