Hyqvia is a combination of Immune Globulin Infusion 10% (Human) (IG 10%) and Recombinant Human Hyaluronidase developed by Halozyme.
The first subcutaneous immune globulin (IG) treatment is 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.
At present, majority of 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.
Immune Deficiency Foundation president and founder Marcia Boyle said 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," Boyle said.
"We commend Baxter for its significant commitment and investment in the development of Hyqvia."
The approval of Hyqvia represents the first US approved Biologics License Application which uses Halozyme’s rHuPH20 platform.
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."
In 2013, Hyqvia was approved in Europe to treat adults (=18 years) with primary immunodeficiency syndromes and myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections.
Currently, the drug is being prescribed in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
The company intends to launch Hyqvia in the US in the coming weeks.
Image: Hyqvia is a combination of Immune Globulin Infusion 10% and Recombinant Human Hyaluronidase indicated to treat PI. Photo: courtesy of Baitong333/ freedigitalphotos.net.