Baxter Provides Update On HyQvia; FDA Extends PDUFA Date - Quick Facts

(RTTNews) - Baxter International Inc. (BAX) and Halozyme Therapeutics, Inc., (HALO) announced the U.S. FDA has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for HYQVIA, investigational subcutaneous treatment for patients with primary immunodeficiency. Baxter said FDA is requiring additional time to review supplemental data that the company provided as part of the ongoing BLA process for HyQvia approval. The PDUFA date has been extended by three months, which is the standard extension period, the company said.

HyQvia is a product consisting of human normal immunoglobulin and recombinant human hyaluronidase, which is licensed from Halozyme Therapeutics. The immunoglobulin provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IG administered subcutaneously, increasing its bioavailability.