FDA advisory panel backs Baxter’s HyQvia for primary immunodeficiency

The Blood Products Advisory Committee (BPAC) of the US Food and Drug Administration has voted 15-1 that HyQvia [immune globulin infusion 10% (human) with recombinant human hyaluronidase], Baxter International’s (NYSE: BAX) investigational subcutaneous treatment for patients with primary immunodeficiency (PI), has a favorable risk/benefit profile.

Approval of the product in the USA has been delayed, following the issue of a Complete Response Letter by the agency, calling for additional preclinical data to address concerns about non-neutralizing antibodies generated against rHuPH20.

HyQvia already approved in Europe