EU bodies back label changes for Ruconest and Xtandi

The European Commission adopted the Committee for Medicinal Products for Human Use  (CHMP) recommendation to include the treatment of hereditary angioedema (HAE) attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that formed part of the EU label for Ruconest (recombinant human C1 inhibitor) from Netherlands-based Pharming (Euronext: PHARM).

The European Medicines Agency’s CHMP also noted that the importance of favorable effects of Ruconest is further supported by the continued availability of supply of Ruconest (produced by recombinant technology) in comparison to supply from blood donor plasma that may vary and not being a blood derived product thereby removing the potential risk of exposure to blood borne pathogens.

This will mean that, effective now, adolescents also have access to (non- blood derived) recombinant C1- inhibitor therapy for the treatment of their angioedema attacks. In addition, the requirement to test HAE patients for pre-existing antibodies against rabbit dander, prior to treatment with Ruconest and following each tenth treatment with Ruconest, has been removed from the label. The requirement for IgE testing was a specific EU request based on a single adverse drug reaction in a study subject. The need for testing was not required in the USA as more safety data were available at the time of the Biologics License Application (BLA) and subsequent Food and Drug Administration ( FDA)-approved label in 2014. The EU patient information leaflet will be updated to reflect these changes over the coming months.

Positive opinion for Astellas/Medivation’s Xtandi