Halozyme Therapeutics Inc., a biopharmaceutical company focused on the development and commercialisation of recombinant human enzymes, and Baxter Healthcare Corporation have received an approval from the US Food and Drug Administration for 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. 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,” said Jonathan Lim, Halozyme's chairman and CEO.
“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. We will continue to work with Halozyme to help clinicians fully realise the drug delivery and administration benefits this product offers,” said Daniel Tasse, general manager of Baxter's anaesthesia, critical care and oncology business.
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, claims a Baxter release.
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.