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news.Baxter International and Halozyme Therapeutics have announced that the US Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its review of the Biologics License Application (BLA) for HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the company’s investigational subcutaneous treatment for patients with primary immunodeficiency (PI).
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The FDA is requiring additional time to review supplemental data that Baxter provided as part of the ongoing BLA process for HyQvia approval. The PDUFA date has been extended by three months, which is the standard extension period.
As part of the FDA’s extended review of the HyQvia BLA amendment, Baxter now expects to participate in a Blood Products Advisory Committee (BPAC) meeting, which the agency has scheduled for 31 July 2014.
HyQvia was approved by the European Commission for EU member states in 2013 and is available in several European countries, including Germany, Netherlands, Sweden, Norway, Denmark, Ireland and Italy.
HyQvia is indicated in Europe as replacement therapy in adults (=18 years) with primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia (CLL) with severe secondary hypogammaglobulinaemia and recurrent infections.