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FDA approves ZLB Behring’s immunodeficiency drug

The FDA has granted marketing approval to ZLB Behring's Vivaglobin, an immunoglobulin replacement therapy to treat patients with primary immunodeficiency.

Vivaglobin represents another treatment option for patients who may not easily tolerate the currently available intravenous method because they have poor venous access or experience serious side effects from that method. The product is also appropriate for those who want the freedom and convenience of safe home self-administration of immunoglobulin replacement therapy.

Primary immunodeficiency is a, usually-genetic, group of disorders that compromise the immune system, leaving people vulnerable to often life-threatening infections. Immunoglobulin has become standard immune replacement therapy for most people living with the disorder receive immunoglobulin replacement therapy.

“This milestone achievement means that thousands of patients with primary immunodeficiencies now have a brand new treatment option that was specifically designed to make their lives easier,” said Paul Perreault, executive vice president, worldwide commercial operations.