This Day On The Street
Continue to site
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here

Baxter Submits Amended BLA To U.S. FDA For HyQvia For Primary Immunodeficiency

Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc. (NASDAQ:HALO) announced today that Baxter has completed submission of an amended biologics license application (BLA) to the United States Food and Drug Administration (FDA) to re-initiate the review process for approval of HyQvia [Immune Globulin Infusion 10% (human) with Recombinant Human Hyaluronidase] facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency (PI).

HyQvia is a combination of human immune globulin (IG) and recombinant human hyaluronidase. Baxter and Halozyme submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period.

''We believe that if approved, HyQvia may become a valuable option for patients with immune deficiency as it allows for the delivery of a full dose of immunoglobulin often in a single site every three to four weeks, in the comfort of a patient’s home,'' said Ludwig Hantson, Ph.D., president of Baxter’s BioScience business. ''As a long-standing leader in the IG market, we are committed to continually developing new treatment options like HyQvia that have the potential to make a meaningful difference in the way patients are treated.''

The original BLA submission for HyQvia was based on results from a Phase III, prospective, open-label, non-controlled multi-center clinical trial, which evaluated the safety and effectiveness of HyQvia in the prevention of acute serious bacterial infections, rate of adverse reactions and the pharmacokinetic parameters compared to immunoglobulin administered intravenously. In the tolerability assessment of HyQvia, the most frequently reported adverse reactions for patients who received HyQvia were local infusion site reactions (such as pain or discomfort, redness, swelling, and itching) and headache, nausea, fatigue and fever.

HyQvia was approved and launched in a number of European countries in the second half of 2013.

About HyQvia

HyQvia is a product consisting of human normal immunoglobulin (IG 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The IG provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG administered subcutaneously, increasing its bioavailability. The IG is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies.

1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
Stocks Under $10

David Peltier uncovers low dollar stocks with serious upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Submit an article to us!
SYM TRADE IT LAST %CHG

Markets

DOW 18,024.06 +183.54 1.03%
S&P 500 2,108.29 +22.78 1.09%
NASDAQ 5,005.3910 +63.9670 1.29%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs