Baxter International Inc. (NYSE:BAX) today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for HyQ, an investigational combination immunoglobulin product for the treatment of patients with primary immunodeficiencies (PI) that includes Immune Globulin (IG) Infusion 10% (Human) and Recombinant Human Hyaluronidase.
The letter requested additional preclinical data to support the biologics license application (BLA). The primary issues raised in the letter focused on non-neutralizing antibodies generated against recombinant human hyaluronidase and the possible effects of these antibodies on reproduction, development and fertility. Baxter plans to file an amendment to the BLA for HyQ following additional discussions with FDA. Individuals enrolled in ongoing HyQ studies in the United States will now be treated with Baxter’s immune globulin therapy without Recombinant Human Hyaluronidase.
HyQ is an investigational, combination product that includes Immune Globulin (IG) Infusion 10% (Human) and Recombinant Human Hyaluronidase, a human enzyme provided by Halozyme Therapeutics that increases the absorption and dispersion of biologics, which are packaged as a kit. IG provides the therapeutic effect of HyQ and the Recombinant Human Hyaluronidase facilitates the dispersion and absorption of the IG. The IG is a 10% solution that is prepared from human plasma and contains a broad spectrum of antibodies.About Baxter International Inc. Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. This release includes forward-looking statements concerning the company’s HyQ biologics license application. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: actions of regulatory bodies and other governmental authorities, satisfaction of regulatory approval requirements, including with respect to data, and other risks identified in Baxter's most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter's website. Baxter does not undertake to update its forward-looking statements.