HALO -21% on delays..Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) today announced that the U.S. Food and Drug Administration (FDA) is requesting additional information to complete its review of the HyQ Biologics License Application (BLA).
Baxter and Halozyme 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.
About HyQ
HyQ is an investigational, combination product that includes Immune Globulin (IG) Infusion 10% (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% solution that is prepared from human plasma and contains a broad spectrum of antibodies.
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