EC grants marketing authorisation to Ruconest

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).

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