Change in Marketing Authorization Terms For Ruconest

The European Commission has adopted the CHMP recommendation to include the treatment of HAE attacks in adolescents with HAE and to remove the requirements for rabbit IgE testing that formed part of the EU label for Ruconest. The 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 US as more safety data were available at the time of the Biologics License Application (BLA) and subsequent FDA-approved label in 2014. The EU patient information leaflet will be updated to reflect these changes over the coming months.

Prof. Bruno Giannetti, MD, PhD, COO of Pharming Group N.V., commented: “This EU label change now also gives adolescents in the EU the long awaited access to treat their HAE attacks with a non- blood derived C1- inhibitor and in addition, the adoption by the European commission of the CHMP recommendation again confirms the well-established safety profile of Ruconest , based on a database of a dozen controlled clinical trials as well as now some 13,000 post-marketing doses of Ruconest provided to HAE patients. We are pleased that the burden on patients and doctors to perform testing prior to and after treatments with Ruconest has been removed and that emergency treatments of HAE attacks in previously untreated HAE patients, that were until now dependent on plasma derived C1INH therapies can now be made with Ruconest, with, as per the CHMP opinion, the added benefit of eliminating risks of exposure to known blood borne pathogens, such as Hepatitis A, B, C, E, HIV, and CJD, as well as continuously (re)-emerging other pathogens.”
(Source: Pharming)

2017-05-31T19:25:12+00:00