The Committee for Medicinal Products for Human Use ( CHMP ) of the European Medicines Agency ( EMA ) has adopted a positive opinion recommending marketing authorization for pediatric indication of HyQvia ( Human Normal Immunoglobulin [ 10% ], Recombinant Human Hyaluronidase ).

Marketing authorization in Europe was obtained in May 2013 for the use of HyQvia as replacement therapy for adult patients with primary and certain secondary immunodeficiencies.
Patients with immunodeficiencies are missing or have malfunctioning components of their immune systems, placing them at greater risk for recurring infections, longer recovery from illness and more risk of potentially life-threatening complications.

HyQvia offers a demonstrated safety and efficacy profile while delivering a full dose of treatment in 1-2 infusion sites, up to once a month ( every three to four weeks ) for many patients, and can be self-administered at home after appropriate training.

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

Source: Baxalta, 2016

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