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Baxter And Halozyme Announce Positive Opinion For HyQvia For Treatment Of Primary And Secondary Immunodeficiencies In The European Union

''Recognizing that the path to approval for any biologic is a long journey, I would like to thank and congratulate the teams at Halozyme and Baxter who have worked tirelessly to advance this therapeutic option for patients,'' said Gregory I. Frost, Ph.D., president and chief executive officer, Halozyme Therapeutics.

About HyQvia

HyQvia is a product consisting of human normal immunoglobulin (IGSC, 10%) and recombinant human hyaluronidase (licensed from Halozyme Therapeutics). The two components are packaged together as a dual vial unit: IGSC provides the therapeutic effect and the recombinant human hyaluronidase facilitates the dispersion and absorption of the IGSC, increasing the bioavailability. The IGSC is a 10% solution that is prepared from human plasma consisting of at least 98% IgG, which contains a broad spectrum of antibodies.

HyQvia is indicated as replacement therapy in adults (≥ 18 years) in primary immunodeficiency syndromes and in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Important Safety Information

HyQvia should not be used by women who are pregnant, or are planning to become pregnant, or are breast-feeding.

About Immunodeficiency Disorders

Primary Immunodeficiencies (PI) are a group of more than 175 disorders in which part of the body’s immune system is missing or does not function properly. Normally, the immune system protects the body from pathogenic microorganisms like bacteria, viruses, and fungi, which can cause infectious diseases. When any part of a person's immune system is absent or dysfunctional, they are more likely to become infected and may take longer to recover from infections. When a defect in the immune system is inherited, it is called primary, or inherited, immune deficiency. It is estimated that as many as six million children and adults are affected by PI worldwide.

Secondary immunodeficiencies develop as a result of a variety of conditions such as malignancies, particularly those of the haematopoietic and lymphoreticular systems, metabolic disease and/or malnutrition. Furthermore, burns or severe infection can also cause defective immune function and poor antibody response. In particular, immunoglobulin therapies are used to treat hypogammaglobulinaemia associated with chronic lymphocytic leukaemia (CLL) and multiple myeloma (MM). These patients may benefit from immunoglobulin replacement therapy in addition to standard treatment of their primary disease.

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