EC amends marketing authorisation for Pharming’s Ruconest to include self-administration

16 January 2017 (Last Updated January 16th, 2017 18:30)

The European Commission (EC) has amended the marketing authorisation for Netherlands-based Pharming Group’s Ruconest (recombinant C1 esterase inhibitor) to include self-administration using the Ruconest administration kit.

EC amends marketing authorisation for Pharming’s Ruconest to include self-administration

The European Commission (EC) has amended the marketing authorisation for Netherlands-based Pharming Group’s Ruconest (recombinant C1 esterase inhibitor) to include self administration using the Ruconest administration kit.

Ruconest is indicated for the treatment of acute attacks in adult and adolescent patients with hereditary angioedema (HAE).

The move follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP).

The Ruconest administration kit will become available for use in various EU markets, once the educational materials are approved by the local authorities.

Pharming Group chief operating officer professor Bruno Giannetti said: “This EU label change is yet another testament to Ruconest’s well-established and favourable safety profile.

“More than 28,000 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.”

Caused by a deficiency of the C1 esterase inhibitor protein, the HAE disease is characterised by spontaneous and recurrent episodes of swelling of the skin in various parts of the body, as well as in the airways and internal organs.

"This EU label change is yet another testament to Ruconest’s well-established and favourable safety profile."

In particular, edema of the throat, nose or tongue is dangerous and can lead to obstruction of the airway passages.

Although there is currently no known cure for HAE, it is possible to treat the symptoms associated with angioedema attacks.

The disease affects about one in 10,000 to one in 50,000 people worldwide.

Ruconest is also being investigated in a Phase II clinical trial for the treatment of HAE in young children aged between two and 13 and evaluated for various additional follow-on indications.


Image: Swollen right hand in a female patient during a hereditary angioedema attack. Photo: courtesy of LucyHAE.