EU CHMP recommends extension of approval allowing self-administration of Ruconest (recombinant human C1 esterase inhibitor) for acute hereditary angioedema- Pharming Group

Pharming Group has announced that following evaluation of a dossier submitted by the Company earlier this year, 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 (recombinant human C1 esterase inhibitor) to the European Commission. This recommendation will allow self-administration of Ruconest for acute hereditary angioedema (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.

Comment: 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 FDA approved label in July 2014.