HALOZYME AND BAXTER ANNOUNCE FDA APPROVAL OF HYLENEX

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Halozyme Therapeutics has announced that the FDA has approved its Hylenex recombinant (hyaluronidase human injection) for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs.

Hylenex recombinant 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 is contraindicated in patients with hypersensitivity to hyaluronidase enzyme or any other ingredients in the formulation.

Results from a clinical trial conducted to support the Hylenex 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.