Results from a clinical trial conducted to support the Hylenex NDA demonstrated no allergic reactions and significantly reduced injection site discomfort. The data showed injection site discomfort (e.g., stinging, burning, other discomfort) of 28% in the saline arm and 3% in the Hylenex arm.
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.
“We are thrilled that the FDA has approved our first NDA filing,” said Dr Jonathan Lim, Halozyme’s Chairman and CEO. “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.”