The Committee for Medicinal Products for Human Use (CHMP), an advisory committee of the European Medicine Agency (EMA), has adopted a positive opinion recommending an extension to the terms of the marketing authorisation for Ruconest to the European Commission. This recommendation will allow self-administration of Ruconest for acute HAE attacks by adolescents and adults with a new custom-designed administration kit. Following normal timelines after the adoption of the positive opinion by CHMP, the final decision from the European Committee is expected in January 2017. It is expected that the kits will become available for use in the various EU markets soon thereafter.
If the CHMP opinion is adopted by the European Commission and the approval of the associated educational materials is granted by national authorities, the new Ruconest self-administration kit will become available for patients, making dealing with an attack simpler. These custom-designed self-administration kits have already been favorably tested by volunteers. These kits are intended to enable patients or their caregivers to treat their HAE attacks in the comfort and privacy of their own homes or at any other place they choose, without the necessity of a healthcare professional (HCP) being present.
Prof. Bruno Giannetti, MD, PhD, Pharming Group N.V. COO, commented:
“This EU label change proposal is yet another testament to Ruconest’s well-established and favorable safety profile. Over 25,000 post-approval vials of Ruconest to treat HAE attacks have now been prescribed, making it a convenient, safe and effective way to stop these attacks. Following approval of this administration kit, it will be as convenient to use Ruconest in the EU as it already is in the US.”
Self-administration (at home or without a HCP present) was granted immediately on approval in the US as a result of more safety data being available at the time of the Biologics License Application (BLA) and subsequent Food and Drug Administration (FDA) approved label in July 2014.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.