HyQvia regulatory update

The European Commission approved an MAA from Baxter for HyQvia as replacement therapy for adults with primary immunodeficiencies. The product is also approved as replacement therapy in adults with in myeloma or chronic lymphocytic leukemia (CLL) with severe secondary hypogammaglobulinemia and recurrent infections. Baxter said it plans to launch the product in the EU this year starting with Germany, followed by Ireland and the U.K.; the company said it does not disclose pricing by product. Baxter is partnered with Halozyme to develop the subcutaneous formulation of IV Gammagard, an IgG antibodies plasma-based therapy, and rHuPH20, a recombinant human PH20 hyaluronidase enzyme, under a 2007 deal (see BioCentury, Sept. 17, 2007). ...