Baxter Submits Amended Biologics License Application For HyQvia To FDA

(RTTNews) - Baxter International Inc. (BAX) and Halozyme Therapeutics, Inc. (HALO), Monday said that Baxter submitted an amended biologics license application or BLA to the United States Food and Drug Administration or FDA to re-initiate the review process for approval of HyQvia facilitated subcutaneous infusion for the treatment of adult patients with primary immunodeficiency. The companies submitted additional preclinical data that was requested from the FDA in 2012, and expect a six-month review period.

HyQvia is a combination of human immune globulin and recombinant human hyaluronidase. 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 were local infusion site reactions, headache, nausea, fatigue and fever. HyQvia was approved and launched in a number of European countries in the second half of 2013.