CHMP grants positive opinion to CSL's Privigen

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the marketing authorization for Privigen (human normal immunoglobulin) 100mg/ml solution for infusion, for replacement therapy in primary immunodeficiency syndromes.

The CHMP recommendation on the drug, which is made by CSL Behring, the US subsidiary of Australia's CSL group, includes conditions such as: congenital agammaglobulinemia and hypogammaglobulinemia; common variable immunodeficiency; severe combined immunodeficiency; Wiskott Aldrich syndrome; myeloma or chronic lymphocytic leukemia with severe secondary hypogammaglobulinemia and recurrent infections. If approved, the drug could also be used for children with congenital AIDS and recurrent infections, as well as for the immunomodulation idiopathic thrombocytopenic purpura in children or adults at high risk of bleeding, or prior to surgery to correct platelet count.