FDA extends PDUFA date for Baxter and Halozyme’s HyQvia

US drugmakers Baxter International (NYSE: BAX) and Halozyme Therapeutics (Nasdaq: HALO) revealed that the US Food and Drug Administration has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application for HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase), the company’s investigational subcutaneous treatment for patients with primary immunodeficiency (PI).

The FDA is requiring additional time to review supplemental data that Baxter 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. As part of the FDA’s extended review of the HyQvia BLA amendment, Baxter now expects to participate in a Blood Products Advisory Committee (BPAC) meeting, which the agency has scheduled for July 31, 2014.

HyQvia already marketed in Europe

HyQvia was approved by the European Commission for European Union member states in 2013 (The Pharma Letter May 22, 2013) and is available in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.