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BAX<> The FDA approves Baxter International's (NYSE:BAX) Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] for the treatment of adult patients with primary immunodeficiency (PI).
Hyqvia's value proposition is less frequent dosing and fewer infusion sites. Patients require only one infusion of Hyqvia every three of four weeks delivered via one injection site. Most PI patients require weekly or bi-weekly infusions delivered via multiple injection sites.
It is the first BLA approved in the U.S. that utilizes Halozyme's (NASDAQ:HALO) rHuPH20 platform. It was approved in Europe last year for the treatment of PI syndromes and myeloma or chronic lymphocytic leukemia with severe seconday hypogammaglobulinemia and recurrent infections.
Hyqvia consists of a 10% solution of IgG prepared from pooled human plasma. This provides the therapeutic effect. The Recombinant Human Hyaluronidase increases the dispersion and absorption of IgG.
Baxter intends to launch Hyqvia in the U.S. in the next few weeks.