FDA issues Complete Response Letter for HyQ (Baxter) for treatment of Primary Immunodeficiencies

The FDA has issued a complete response letter for HyQ, an investigational combination immunoglobulin product from Baxter for the treatment of patients with Primary Immunodeficiencies that includes Immune Globulin (IG) Infusion 10% (Human) and Recombinant HumanHyaluronidase. The letter requested additional preclinical data to support the biologics license application. 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.