Baxter International Inc. (NYSE:BAX) and Halozyme Therapeutics, Inc., (NASDAQ:HALO) today announced that the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) voted 15-1 that HyQvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], Baxter’s investigational subcutaneous treatment for patients with primary immunodeficiency (PI), has a favorable risk/benefit profile.
HyQvia was approved in Europe in 2013 for adults (≥18 years) with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinaemia and recurrent infections.
Data presented at today’s advisory committee meeting included a review of the preclinical and clinical data supporting the HyQvia application. The FDA will consider the recommendation from the BPAC in its review of Baxter’s amendment to the Biologics License Application (BLA) submitted in December 2013. The company expects the FDA response in the third quarter.
''We are hopeful that the positive support for HyQvia is the next step toward providing a new treatment option for patients with primary immunodeficiency in the United States. We look forward to working closely with the FDA as it completes its review,'' said Ludwig Hantson, Ph.D., president of Baxter BioScience.''Today’s BPAC vote underscores the strength of the HyQvia data and our rHuPH20 platform,'' commented Dr. Helen Torley, President and Chief Executive Officer of Halozyme. ''Our rHuPH20 platform has been studied in thousands of patients spanning multiple disease states and a number of approved products.'' HyQvia was approved by the European Commission for EU member states in 2013 and is currently being prescribed in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy. 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.
Select the service that is right for you!COMPARE ALL SERVICES
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV