EMA changes attitude towards Rhucin

09.07.10 The EU’s Committee for Human Medicinal Products (CHMP) has changed its mind, and is now recommending Pharming NV’s (Leiden) C1 esterase inhibitor Rhucin for the treatment of rapid tissue swelling (edema) in patients with the orphan disease Hereditary Angioedema (HAE). The experts also re­commended changing the product’s name to Ruconest, because there is also a drug marketed under a name similar to “Rhucin” in the EU. In 2008, the CHMP rejected recommending the drug derived from the milk of transgenic rabbits because an ELISA designed to detect host-related impurities was not properly validated. Additionally, the CHMP was concerned over the anti­genicity and efficacy of the product in severe cases of HAE. An assessment report detailing the reasons why the Committee now concluded that there is a favourable benefit/risk ratio will be published together with the marketing authorisation in September. The drug, which targets a EUR110m EU market, will compete with Shire’s Firazyr (Icatibant) and CSL Behring’s Berinert (C1-1NH).