| 2 min read
Register for free to listen to this article
Listen with Speechify
0:00
2:00
DEERFIELD, Ill. & SAN DIEGO—Baxter International Inc. and Halozyme Therapeutics Inc. recently announced top-line results of a Phase III study of HyQ, an investigational facilitated subcutaneous immune globulin (IG) product for use in patients with primary immunodeficiency (PI), reporting that their data "confirm the interim results presented late in 2010 and support the recent submission of a Biologics License Application (BLA) to the United States Food and Drug Administration."

Speaking of the positive data around the product, subcutaneous administration of which is facilitated by recombinant human hyaluronidase, an enzyme that increases dispersion and absorption of the IG, the president of Baxter's BioScience business, Ludwig Hantson, says:
"Completion of this important trial brings us closer to providing an option that can address the needs of patients with immune deficiency disorders."

"Patients with primary immune deficiencies have a chronic, life-long condition that requires diligent, ongoing treatment," notes Dr. Richard L. Wasserman, clinical professor of pediatrics at University of Texas Southwestern Medical School, and an investigator in the HyQ phase III trial. "Physicians who are treating these patients will welcome this new option."

The completion of the phase III trial established a foundation for the HyQ extension study that will further evaluate HyQ administration to patients through March 2012. In addition to the recent regulatory submission in the United States, Baxter expects to file in Europe and Canada in the coming months, and will present results from the phase III study by the end of 2011.

"Submission of this BLA for HyQ represents a significant achievement for Halozyme and Baxter," says Dr. Gregory I. Frost, Halozyme's president and CEO. "Most importantly, these efforts represent the commitment of our scientists and clinicians to developing new treatment options for patients with primary immunodeficiency."

The phase III prospective, open-label, study enrolled 89 patients with PI in 15 centers in the United States and Canada, and evaluated the effectiveness of HyQ in the prevention of infections and measured other secondary endpoints including tolerability.

The objective of the study was to infuse a three-week or four-week dose of 10 percent HyQ in a single infusion site. In the study, the acute serious bacterial infection rate was 0.025 per patient per year, which is below the required efficacy threshold of 1.0. In the tolerability assessment of HyQ, the most frequently reported adverse reactions were infusion site reactions (20 percent of infusions), headache (3 percent of infusions), fatigue (1 percent of infusions) and pyrexia (fever) (1 percent of infusions).

About the Author

Related Topics

Loading Next Article...
Loading Next Article...
Subscribe to Newsletter

Subscribe to our eNewsletters

Stay connected with all of the latest from Drug Discovery News.

Subscribe

Sponsored

GreenCooling

Thermo Scientific™ Centrifuges with GreenCool Technology

Next-generation natural refrigerant cooling system for centrifuges, offering a lower Global Warming Potential and reduced energy consumption.
Clear sample tubes are shown in a clear tote with red lids in a sample prep robot with a blue and silver industrial lab background.

The crucial role of sample preparation in biotherapy manufacturing

Discover how better sample preparation can unlock improved assay accuracy and analytical results.
A black mosquito is shown on pink human skin against a blurred green backdrop.

Discovering deeper insights into malaria research

Malaria continues to drive urgent research worldwide, with new therapies and tools emerging to combat the parasite’s complex lifecycle and global burden.
Drug Discovery News March 2025 Issue
Latest IssueVolume 21 • Issue 1 • March 2025

March 2025

March 2025 Issue

Explore this issue