Hizentra indicated for new treatment as approval granted for CIDP.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Hizentra (immune globulin subcutaneous [human]), from CSL Behring. The CHMP adopted a new indication as follows: “Immunomodulatory therapy in adults, children and adolescents (0-18 years): Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.”

The full indications for Hizentra will be as follows: Replacement therapy in adults, children and adolescents (0-18 years) in: • Primary immunodeficiency syndromes with impaired antibody production. • Hypogammaglobulinaemia and recurrent bacterial infections in patients with chronic lymphocytic leukaemia (CLL), in whom prophylactic antibiotics have failed or are contra-indicated. • Hypogammaglobulinaemia and recurrent infections in multiple myeloma (MM) patients. • Hypogammaglobulinaemia in patients, pre- and post-allogeneic haematopoietic stem cell transplantation (HSCT). Immunomodulatory therapy in adults, children and adolescents (0-18 years): • Hizentra is indicated for the treatment of patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with IVIg.