Halozyme and Baxter Announce FDA Approval of Hylenex
Halozyme Therapeutics and Baxter Healthcare Corporation Announce FDA Approval of Hylenex
Approval Marks the First Recombinant Human Hyaluronidase Approved for Use as an Adjuvant Drug to Increase the Absorption and Dispersion of Other Injected Drugs
SAN DIEGO, and DEERFIELD, Ill., December 5, 2005 -- Halozyme Therapeutics, Inc. , a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, and Baxter Healthcare Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved Halozyme's Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs. Baxter will market and sell Hylenex, a proprietary recombinant human hyaluronidase, in the United States.
"We are thrilled that the FDA has approved our first NDA filing," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "This is a landmark achievement for Halozyme. We believe Hylenex will help enhance the practice of medicine by offering healthcare providers and their patients a human recombinant product as an adjuvant to increase the absorption of other injected drugs."
"We look forward to using our expertise and strong channels to successfully launch Hylenex, allowing patients in many clinical settings to benefit from the product manufactured with this promising technology," said Daniel Tasse, general manager of Baxter's Anesthesia, Critical Care and Oncology business. "We will continue to work with Halozyme to help clinicians fully realize the drug delivery and administration benefits this product offers."
Results from a clinical trial conducted to support the Hylenex NDA demonstrated no allergic reactions to Hylenex and significantly reduced injection site discomfort. The double-blinded clinical study compared Hylenex to a saline control in 100 human volunteers. These volunteers were injected intradermally with Hylenex in one forearm and saline control in the other forearm, and evaluated for allergic responses and injection site side effects. The data showed injection site discomfort (e.g., stinging, burning, other discomfort) of 28% in the saline arm and 3% in the Hylenex arm.
Hylenex recombinant (hyaluronidase human injection) is indicated for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. Hylenex recombinant is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation. The contraindications and warnings regarding the use of Hylenex should be recognized and adhered to prior to prescription or administration.
Source: Halozyme Therapeutics, Inc.
Posted: December 2005