Baxter and Halozyme have received approval from the US Food and Drug Administration (FDA) for Hyqvia to treat adult patients with primary immunodeficiency (PI).
Hyqvia is a combination of Immune Globulin Infusion 10% (Human) (IG 10%) and Recombinant Human Hyaluronidase. It is also the first subcutaneous immune globulin (IG) treatment approved for PI patients with a dosing regimen requiring only one infusion up to once per month and one injection site per infusion to deliver a full therapeutic dose of IG.
Baxter BioScience president Ludwig Hantson said: "The availability of HYQVIA has a significant impact on the treatment of PI, allowing for effective delivery of a full therapeutic dose of IG less frequently than other subcutaneous treatments (up to once a month), while maintaining the efficacy, safety and tolerability profile that is most important for patients."
Currently, most of the patients with PI receive intravenous infusions in a doctor’s office or infusion center, and the existing subcutaneous IG treatments require weekly or bi-weekly treatment with multiple infusion sites per treatment.
Halozyme president and CEO Helen Torley said: "Today’s FDA approval of HYQVIA is a significant milestone for Halozyme as it represents the first US approved Biologics License Application which utilizes our rHuPH20 platform."
Baxter plans to introduce Hyqvia in the US in the coming weeks.
In 2013, Hyqvia has secured approval in Europe to treat adults with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections.
At present, the drug is being prescribed in different European countries such as Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.