EC gives ViroPharma Cinryze go-ahead

The European Commission has granted ViroPharma Centralised Marketing Authorisation for Cinryze (C1 inhibitor [human]) in adults and adolescents with hereditary angioedema (HAE), a rare, debilitating and potentially life-threatening genetic disorder that affects at least 10,000 people in the region.  

The approval is for routine prevention, pre-procedure prevention and acute treatment of angioedema attacks. It also includes a self-administration option for appropriately trained patients included in the Summary of Product Characteristics.

The therapeutic indication in Europe is for treatment and pre-procedure prevention of angioedema attacks in adults and adolescents with HAE and routine prevention of angioedema attacks in adults and adolescents with severe and recurrent attacks of HAE, who are intolerant to or insufficiently protected by oral prevention treatments or patients who are inadequately managed with repeated acute treatment.

Vincent Milano, ViroPharma's president and chief executive, said: "The approval of Cinryze throughout Europe is an important milestone for ViroPharma in our evolution as an international biopharmaceutical company that delivers novel solutions that address the unmet medical needs of patients living with few, if any, clinical treatment options. 

"We are thrilled to bring this important new therapy to European HAE patients seeking a more normal life through the prevention and treatment of their attacks."

The approval of Cinryze follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in March 2011. 

Cinryze is now approved throughout all the Member States of the European Union (EU) as well as in the European Economic Area (EEA), namely Norway, Iceland and Liechtenstein.