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FDA Questions Treatment for Immune Deficiency Disorders
HyQ is an investigational product that includes plasma-derived immune globulin 10% and Halozyme's recombinant human hyaluronidase (rHuPH20) for subcutaneous administration in patients with primary immunodeficiency disease.
The FDA’s letter requested additional preclinical data to support the 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. Elevated anti-rHuPH20 antibody titers were detected in the registration trial but have not been associated with adverse events.
While waiting for the companies to provide additional data, CBER has directed that patients should no longer be dosed with rHuPH20 in the Baxter and ViroPharma clinical studies.
Read the news release on Halozyme's Web site.