FDA approves Baxter/Halozyme’s HyQvia

The US Food and Drug Administration on Friday approved Baxter International’s (NYSE: BAX) and Halozyme Therapeutics’ (Nasdaq: HALO) subcutaneous treatment for adult patients with primary immunodeficiency (PI), HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase).

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 majority of PI patients today receive intravenous infusions in a doctor’s office or infusion center, and current subcutaneous IG treatments require weekly or bi-weekly treatment with multiple infusion sites per treatment.

''Patients with PI value treatments that offer efficacy, safety and tolerability. Since each person with PI responds differently to treatment, having options that meet these individual needs is critically important,'' commented Marcia Boyle, president and founder of the Immune Deficiency Foundation, adding: ''We commend Baxter for its significant commitment and investment in the development of HyQvia.''