EC grants marketing authorisation to Ruconest
For the treatment of acute attacks of hereditary angioedema
The European Commission has granted Dutch biotech firm Pharming marketing authorisation for its lead product Ruconest for the treatment of acute attacks of Hereditary Angioedema (HAE).
Pharming will now receive a €5m milestone payment from marketing and distribution partner Swedish Orphan Biovitrum (Sobi).
Following the unanimous positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP), Ruconest’s marketing authorisation has now been ratified by the European Committee.
Patients suffering from HAE experience unpredictable, painful and debilitating attacks, due to reduced levels of C1 inhibitor, resulting in intense swelling of parts of the body (for example, face, throat, abdomen), which can last up to five days if left untreated. Ruconest is a recombinant version of the human C1 inhibitor protein, produced by Pharming’s proprietary transgenic technology.
Ruconest is now approved for use in the 27 EU countries plus Norway, Iceland and Liechtenstein. Sobi will launch Ruconest initially in Germany, the UK, Sweden, Finland and Denmark, followed by a rolling launch in each of the other European Area countries.
Sijmen de Vries, chief executive of Pharming, said: ‘The granting of marketing authorisation for Ruconest is a very important step in Pharming’s evolution from a drug development company to a commercial specialist pharmaceutical business.’
