FDA Approves First Human Recombinant Hyaluronidase
Hylenex is an adjuvant that can increase the absorption, dispersion of injected drugs
TUESDAY, Dec. 6 (HealthDay News) -- The U.S. Food and Drug Administration approved the first recombinant version of human hyaluronidase, Hylenex, for use as an adjuvant to increase the absorption and dispersion of other injected drugs.
Hylenex can be used for hypodermoclysis and as an adjunct in subcutaneous urography for improving the resorption of radiopaque agents, according to manufacturer, Halozyme Therapeutics, which develops recombinant human enzymes for infertility, ophthalmology and oncology. "We are thrilled that the FDA has approved our first NDA filing," Jonathan Lim, M.D., Halozyme's chairman and CEO, said in a statement.
Hylenex is contraindicated in patients who are hypersensitive to hyaluronidase enzyme or any of its other ingredients.
Baxter Healthcare, principal U.S. subsidiary of Baxter International Inc., will market and sell the drug in the United States.