EU amends marketing authorisation for Ruconest (recombinant human C1 esterase inhibitor) to include self administration in acute hereditary angioedema- Pharming Group

Pharming Group has announced that following the positive opinion of the Committee for Medicinal Products for Human Use, the European Commission has adopted the Commission Implementing Decision to amend the marketing authorisation for Ruconest (recombinant human C1 esterase inhibitor) to include self administration using the Ruconest Administration Kit. This decision allows for self-administration of Ruconest for acute hereditary angioedema (HAE) attacks by adolescents and adults with a new custom-designed Ruconest Administration Kit 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. The Administration Kit will become available for use in the various EU markets, following approval of the Educational Materials by the local authorities, expected over the coming one to three months.

Comment: Self-administration (at home or without a HCP present) was granted immediately upon approval in the US as a result of more safety data being available at the time of the Biologics License Application (BLA) and subsequent approval in July 2014.