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FDA Advisors Give ‘Thumbs Up’ to Immune Therapy HyQvia

Approval decision expected in third quarter of 2014

The FDA’s Blood Products Advisory Committee (BPAC) has voted 15 to 1 that HyQvia (immunoglobulin infusion 10% [human] with recombinant human hyaluronidase, Baxter International/Halozyme Therapeutics), an investigational subcutaneous treatment for patients with primary immunodeficiency, has a favorable risk–benefit profile.

HyQvia was approved in Europe in 2013 for adults (18 years of age or older) with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections.

Data presented to BPAC at a July 31 meeting included a review of the preclinical and clinical data supporting the biologics license application (BLA) for HyQvia. The FDA will consider the committee’s recommendation in its review of the BLA, which was submitted in December 2013. An approval decision is expected in the third quarter of 2014.

HyQvia consists of human normal immunoglobulin and recombinant human hyaluronidase. The immunoglobulin provides the therapeutic effect, and the hyaluronidase facilitates the dispersion and absorption of the immunoglobulin administered subcutaneously, increasing its bioavailability. The immunoglobulin is a 10% solution that is prepared from human plasma consisting of at least 98% immunoglobulin G (IgG), which contains a broad spectrum of antibodies.

Source: Baxter; July 31, 2014.

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Decision supported by data from more than 4,000 patients