The US Food and Drug Administration has approved Baxter International and Halozyme Therapeutics’ Hyqvia for the treatment of adults with primary immunodeficiency.

The thumbs-up for Hyqvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) makes it the first subcutaneous IG treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month and one injection site. Baxter noted that the majority of PI patients currently receive intravenous infusions in a doctor’s office or infusion centre and current subcutaneous IG treatments require weekly or bi-weekly treatment with multiple infusion sites.

Marcia Boyle, president of the Immune Deficiency Foundation, said that “since each person with PI responds differently to treatment, having options that meet these individual needs is critically important”.  

The approval is a major boost for Baxter and Halozyme given that the FDA rejected Hyqvia, then known as HyQ, in 2012. It was approved in Europe last year for the treatment of PI syndromes and myeloma or chronic lymphocytic leukaemia with severe seconday hypogammaglobulinemia and recurrent infections.

Baxter intends to launch Hyqvia in the USA in the coming weeks.