FDA Approves Hyqvia for Treating Adults With Primary Immunodeficiency

Baxter International Inc. and Halozyme Therapeutics Inc. Sept. 12 announced that the Food and Drug Administration has approved Hyqvia [immune globulin infusion 10 percent (Human) with recombinant human hyaluronidase] for the treatment of adult patients with primary immunodeficiency (PI).

Hyqvia is the first subcutaneous immune globulin (IG) treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month (every three to four weeks) and one injection site per infusion to deliver a full therapeutic dose of IG, the companies said.

Baxter said it expects to launch Hyqvia in the U.S. in the coming ...