FDA committee supports HyQ via for Primary Immune Deficiency - Baxter

The Blood Products Advisory Committee (BPAC) of the FDA voted 15-1 that HyQ via (subcutaneous immune globulin with recombinant human hyaluronidase), from Baxter, for patients with Primary Immune Deficiency, has a favorable risk/benefit profile. Data presented at the advisory committee meeting included a review of the preclinical and clinical data supporting the HyQ via application.

The FDA will consider the recommendation from the BPAC in its review of Baxter�s amendment to the Biologics License Application submitted in December 2013. The company expects the FDA response in the third quarter. 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.