BioCentury
ARTICLE | Company News

Baxter resubmits HyQvia BLA

December 3, 2013 1:45 AM UTC

Baxter International Inc. (NYSE:BAX) resubmitted a BLA to FDA for HyQvia as replacement therapy to treat adults with primary immunodeficiency associated with defects in humoral immunity. The resubmission contains preclinical data requested by FDA in an August 2012 complete response letter. The European Commission approved HyQvia -- a subcutaneous formulation of IV Gammagard, an IgG antibodies plasma-based therapy, and rHuPH20, a recombinant human PH20 hyaluronidase enzyme -- in May (see BioCentury Extra, May 21). ...