The US Food and Drug Administration (FDA) has requested Baxter International Inc. and Halozyme Therapeutics, Inc. to provide additional information to complete its review of the HyQ Biologics License Application (BLA).

Baxter and Halozyme have announced that they will work closely together to develop studies to provide additional data to address concerns raised by the FDA related to the long-term chronic use of HyQ. The companies now expect to participate in a meeting of the FDA's Blood Products Advisory Committee concerning the agency's request for additional data. The companies expect these requests to require additional time to complete and to delay the companies' anticipated regulatory review and approval timeline.

HyQ is an investigational, combination product that includes Immune Globulin (IG) Infusion 10 per cent (Human) and Recombinant Human Hyaluronidase, 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 per cent solution that is prepared from human plasma and contains a broad spectrum of antibodies.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.

Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care.